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出境医 / 临床实验 / White Matter Connections and Memory: the STRATEGIC Study (STRATEGIC)

White Matter Connections and Memory: the STRATEGIC Study (STRATEGIC)

Study Description
Brief Summary:
In patients who have had a stroke, memory problems are common. Some patients with memory problems improve over the first year after stroke, but recovery is unpredictable. The STRATEGIC study assesses patients with recent stroke and follows them up after one year. The study uses cognitive testing and advanced MRI to understand the brain's mechanism for recovery from memory problems and to identify factors that may predict later recovery.

Condition or disease
Stroke Cognitive Impairment Memory Impairment

Detailed Description:

Memory breakdown in older age is a major challenge for medical research, with an increasing burden in personal, societal and fiscal terms. Stroke is an important cause. Memory depends on widespread networks in the brain which are bound together by white matter connections, which essentially act as the wiring of brain networks. This project uses a technique called diffusion tensor MRI to investigate these connections and their relationship to brain function and patterns of memory impairment after stroke.

Previous research showed that a tract called the fornix was most important in the healthy brain and in ageing. However, in individuals at an early stage of memory decline alternative pathways became disproportionately more important. This led to the idea that individuals with early memory decline might be especially vulnerable to injury to these alternative tracts from stroke. The purpose of this project is to test this idea.

The project focuses on patients with recent stroke. Participants undergo MRI, including diffusion tensor MRI, and in-depth testing of memory and other cognitive functions. The pattern of damage to temporal lobe connections in the brain will be assessed and related to the impact of brain infarction on memory. Analysis will determine how undamaged tracts contribute to recovery over one year. Finally, cutting edge computational image analysis techniques will be applied to try and predict memory profile in more detail and extract maximum information about prognosis from brain images.

Study Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 193 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: White Matter Connections and Memory: the STRATEGIC Study
Actual Study Start Date : April 11, 2014
Actual Primary Completion Date : June 7, 2017
Estimated Study Completion Date : April 30, 2022
Arms and Interventions
Group/Cohort
Stroke patients
Patients with recent ischaemic stroke
Outcome Measures
Primary Outcome Measures :
  1. Montreal Cognitive Assessment (MoCA) score at 30-90 days [ Time Frame: 30-90 days after stroke ]

    The MoCA is a widely used test measuring across several cognitive domains. It gives a score out of 30.

    https://www.mocatest.org


  2. Montreal Cognitive Assessment (MoCA) score at one year [ Time Frame: One year after stroke ]

    The MoCA is a widely used test measuring across several cognitive domains. It gives a score out of 30.

    https://www.mocatest.org


  3. Montreal Cognitive Assessment (MoCA), change in score over one year [ Time Frame: From 30-90 days after stroke to one year after stroke ]

    The MoCA is a widely used test measuring across several cognitive domains. It gives a score out of 30.

    https://www.mocatest.org


  4. Verbal free recall score on the Free and Cued Selective Reminding Task (FSCRT) at 30-90 days [ Time Frame: 30-90 days after stroke ]
    The FCSRT tests how well participants can remember 16 words. Participants make three attempts, giving a total score out of 48. The test has been widely used in studies of memory and is described in Grober, E., & Buschke, H. (1987). Genuine memory deficits in dementia. Developmental Neuropsychology, 3, 13-36.

  5. Verbal free recall score on the Free and Cued Selective Reminding Task (FSCRT) at one year [ Time Frame: One year after stroke ]
    The FCSRT tests how well participants can remember 16 words. Participants make three attempts, giving a total score out of 48. The test has been widely used in studies of memory and is described in Grober, E., & Buschke, H. (1987). Genuine memory deficits in dementia. Developmental Neuropsychology, 3, 13-36.

  6. Verbal free recall score on the Free and Cued Selective Reminding Task (FSCRT), change in score over one year [ Time Frame: From 30-90 days after stroke to one year after stroke ]
    The FCSRT tests how well participants can remember 16 words. Participants make three attempts, giving a total score out of 48. The test has been widely used in studies of memory and is described in Grober, E., & Buschke, H. (1987). Genuine memory deficits in dementia. Developmental Neuropsychology, 3, 13-36.

  7. Backward digit span score at 30-90 days [ Time Frame: 30-90 days after stroke. ]
    The digit span test measures working memory and is taken from the Wechsler Adult Intelligence Scale IV. In the test participants must repeat a sequence of digits. Sequences are repeated at increasing length until the participant makes two errors at the same length. The test comprises two parts. In the first, participants repeat sequences is the order given; in the second they repeat sequences in reverse order. This outcome measure takes the total correct responses in reverse order. Sequence lengths are between two and seven digits, with to sequences of each length, giving a maximum score of 12.

  8. Backward digit span score at one year [ Time Frame: One year after stroke ]
    The digit span test measures working memory and is taken from the Wechsler Adult Intelligence Scale IV. In the test participants must repeat a sequence of digits. Sequences are repeated at increasing length until the participant makes two errors at the same length. The test comprises two parts. In the first, participants repeat sequences is the order given; in the second they repeat sequences in reverse order. This outcome measure takes the total correct responses in reverse order. Sequence lengths are between two and seven digits, with to sequences of each length, giving a maximum score of 12.

  9. Backward digit span score, change in score over one year [ Time Frame: From 30-90 days after stroke to one year after stroke ]
    The digit span test measures working memory and is taken from the Wechsler Adult Intelligence Scale IV. In the test participants must repeat a sequence of digits. Sequences are repeated at increasing length until the participant makes two errors at the same length. The test comprises two parts. In the first, participants repeat sequences is the order given; in the second they repeat sequences in reverse order. This outcome measure takes the total correct responses in reverse order. Sequence lengths are between two and seven digits, with to sequences of each length, giving a maximum score of 12.

  10. Paired Associate Learning (PAL) recognition score at 30-90 days [ Time Frame: 30-90 days after stroke. ]
    The PAL task measures participants' ability to associate two items of information in memory. In this study, participants must learn a set of ten objects and their associated locations. The recognition score is the number of correct choices when given two possible locations for a given object. Each object is tested three times, giving a maximum score of 30.

  11. Paired Associate Learning (PAL) recognition score at one year [ Time Frame: One year after stroke. ]
    The PAL task measures participants' ability to associate two items of information in memory. In this study, participants must learn a set of ten objects and their associated locations. The recognition score is the number of correct choices when given two possible locations for a given object. Each object is tested three times, giving a maximum score of 30.

  12. Paired Associate Learning (PAL) recognition score, change in score over one year [ Time Frame: From 30-90 days after stroke to one year after stroke ]
    The PAL task measures participants' ability to associate two items of information in memory. In this study, participants must learn a set of ten objects and their associated locations. The recognition score is the number of correct choices when given two possible locations for a given object. Each object is tested three times, giving a maximum score of 30.

  13. Paired Associate Learning (PAL) recall score at 30-90 days [ Time Frame: 30-90 days after stroke ]
    The PAL task measures participants' ability to associate two items of information in memory. In this study, participants must learn a set of ten objects and their associated locations. The recall score measures participants ability to recall which object was present at each location (a maximum of 10).

  14. Paired Associate Learning (PAL) recall score at one year [ Time Frame: One year after stroke ]
    The PAL task measures participants' ability to associate two items of information in memory. In this study, participants must learn a set of ten objects and their associated locations. The recall score measures participants ability to recall which object was present at each location (a maximum of 10).

  15. Paired Associate Learning (PAL) recall score, change in score over one year [ Time Frame: From 30-90 days after stroke to one year after stroke ]
    The PAL task measures participants' ability to associate two items of information in memory. In this study, participants must learn a set of ten objects and their associated locations. The recall score measures participants ability to recall which object was present at each location (a maximum of 10).

  16. Process Dissociation Procedure (PDP) familiarity score at 30-90 days [ Time Frame: 30-90 days after stroke ]
    The PDP is a word memory test. Participants first read out loud a set of words. They are then presented with incomplete words and must fill in the missing letters. In one part of the test, participants must use one of the remembered words whenever possible. In the other part of the test, they must avoid the remembered words. The two parts are designed to dissociate two types of memory: familiarity and recollection. Familiarity is the unconscious remembering of a word because it was previously seen, which is an advantage when including the words, but a disadvantage when avoiding them. Recollection is the conscious remembering of a word and the context where it was encountered. This is an advantage in both parts of the test. The scores in each part of the test are combined to compute scores for familiarity and recollection, each in percent.

  17. Process Dissociation Procedure (PDP) familiarity score at one year [ Time Frame: One year after stroke ]
    The PDP is a word memory test. Participants first read out loud a set of words. They are then presented with incomplete words and must fill in the missing letters. In one part of the test, participants must use one of the remembered words whenever possible. In the other part of the test, they must avoid the remembered words. The two parts are designed to dissociate two types of memory: familiarity and recollection. Familiarity is the unconscious remembering of a word because it was previously seen, which is an advantage when including the words, but a disadvantage when avoiding them. Recollection is the conscious remembering of a word and the context where it was encountered. This is an advantage in both parts of the test. The scores in each part of the test are combined to compute scores for familiarity and recollection, each in percent.

  18. Process Dissociation Procedure (PDP) familiarity score, change in score over one year [ Time Frame: From 30-90 days after stroke to one year after stroke ]
    The PDP is a word memory test. Participants first read out loud a set of words. They are then presented with incomplete words and must fill in the missing letters. In one part of the test, participants must use one of the remembered words whenever possible. In the other part of the test, they must avoid the remembered words. The two parts are designed to dissociate two types of memory: familiarity and recollection. Familiarity is the unconscious remembering of a word because it was previously seen, which is an advantage when including the words, but a disadvantage when avoiding them. Recollection is the conscious remembering of a word and the context where it was encountered. This is an advantage in both parts of the test. The scores in each part of the test are combined to compute scores for familiarity and recollection, each in percent.

  19. Process Dissociation Procedure (PDP) recollection score at 30-90 days [ Time Frame: 30-90 days after stroke ]
    The PDP is a word memory test. Participants first read out loud a set of words. They are then presented with incomplete words and must fill in the missing letters. In one part of the test, participants must use one of the remembered words whenever possible. In the other part of the test, they must avoid the remembered words. The two parts are designed to dissociate two types of memory: familiarity and recollection. Familiarity is the unconscious remembering of a word because it was previously seen, which is an advantage when including the words, but a disadvantage when avoiding them. Recollection is the conscious remembering of a word and the context where it was encountered. This is an advantage in both parts of the test. The scores in each part of the test are combined to compute scores for familiarity and recollection, each in percent.

  20. Process Dissociation Procedure (PDP) recollection score at one year [ Time Frame: One year after stroke ]
    The PDP is a word memory test. Participants first read out loud a set of words. They are then presented with incomplete words and must fill in the missing letters. In one part of the test, participants must use one of the remembered words whenever possible. In the other part of the test, they must avoid the remembered words. The two parts are designed to dissociate two types of memory: familiarity and recollection. Familiarity is the unconscious remembering of a word because it was previously seen, which is an advantage when including the words, but a disadvantage when avoiding them. Recollection is the conscious remembering of a word and the context where it was encountered. This is an advantage in both parts of the test. The scores in each part of the test are combined to compute scores for familiarity and recollection, each in percent.

  21. Process Dissociation Procedure (PDP) recollection score, change in score over one year [ Time Frame: From 30-90 days after stroke to one year after stroke ]
    The PDP is a word memory test. Participants first read out loud a set of words. They are then presented with incomplete words and must fill in the missing letters. In one part of the test, participants must use one of the remembered words whenever possible. In the other part of the test, they must avoid the remembered words. The two parts are designed to dissociate two types of memory: familiarity and recollection. Familiarity is the unconscious remembering of a word because it was previously seen, which is an advantage when including the words, but a disadvantage when avoiding them. Recollection is the conscious remembering of a word and the context where it was encountered. This is an advantage in both parts of the test. The scores in each part of the test are combined to compute scores for familiarity and recollection, each in percent.


Biospecimen Retention:   Samples With DNA
Blood

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with recent ischaemic stroke.
Criteria

Inclusion Criteria:

  • Aged over 50 years
  • Recent ischaemic stroke
  • English is first language

Exclusion Criteria:

  • Previous large artery infarct
  • Major neurological or psychiatric condition
  • Moderate to severe head injury (Mayo classification)
  • Dementia
  • Severe cardiac failure
  • Active malignancy
Contacts and Locations

Sponsors and Collaborators
King's College London
Investigators
Layout table for investigator information
Principal Investigator: Michael J O'Sullivan, MBBS,PhD King's College London and University of Queensland
Tracking Information
First Submitted Date November 23, 2018
First Posted Date June 11, 2019
Last Update Posted Date June 11, 2019
Actual Study Start Date April 11, 2014
Actual Primary Completion Date June 7, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 7, 2019)
  • Montreal Cognitive Assessment (MoCA) score at 30-90 days [ Time Frame: 30-90 days after stroke ]
    The MoCA is a widely used test measuring across several cognitive domains. It gives a score out of 30. https://www.mocatest.org
  • Montreal Cognitive Assessment (MoCA) score at one year [ Time Frame: One year after stroke ]
    The MoCA is a widely used test measuring across several cognitive domains. It gives a score out of 30. https://www.mocatest.org
  • Montreal Cognitive Assessment (MoCA), change in score over one year [ Time Frame: From 30-90 days after stroke to one year after stroke ]
    The MoCA is a widely used test measuring across several cognitive domains. It gives a score out of 30. https://www.mocatest.org
  • Verbal free recall score on the Free and Cued Selective Reminding Task (FSCRT) at 30-90 days [ Time Frame: 30-90 days after stroke ]
    The FCSRT tests how well participants can remember 16 words. Participants make three attempts, giving a total score out of 48. The test has been widely used in studies of memory and is described in Grober, E., & Buschke, H. (1987). Genuine memory deficits in dementia. Developmental Neuropsychology, 3, 13-36.
  • Verbal free recall score on the Free and Cued Selective Reminding Task (FSCRT) at one year [ Time Frame: One year after stroke ]
    The FCSRT tests how well participants can remember 16 words. Participants make three attempts, giving a total score out of 48. The test has been widely used in studies of memory and is described in Grober, E., & Buschke, H. (1987). Genuine memory deficits in dementia. Developmental Neuropsychology, 3, 13-36.
  • Verbal free recall score on the Free and Cued Selective Reminding Task (FSCRT), change in score over one year [ Time Frame: From 30-90 days after stroke to one year after stroke ]
    The FCSRT tests how well participants can remember 16 words. Participants make three attempts, giving a total score out of 48. The test has been widely used in studies of memory and is described in Grober, E., & Buschke, H. (1987). Genuine memory deficits in dementia. Developmental Neuropsychology, 3, 13-36.
  • Backward digit span score at 30-90 days [ Time Frame: 30-90 days after stroke. ]
    The digit span test measures working memory and is taken from the Wechsler Adult Intelligence Scale IV. In the test participants must repeat a sequence of digits. Sequences are repeated at increasing length until the participant makes two errors at the same length. The test comprises two parts. In the first, participants repeat sequences is the order given; in the second they repeat sequences in reverse order. This outcome measure takes the total correct responses in reverse order. Sequence lengths are between two and seven digits, with to sequences of each length, giving a maximum score of 12.
  • Backward digit span score at one year [ Time Frame: One year after stroke ]
    The digit span test measures working memory and is taken from the Wechsler Adult Intelligence Scale IV. In the test participants must repeat a sequence of digits. Sequences are repeated at increasing length until the participant makes two errors at the same length. The test comprises two parts. In the first, participants repeat sequences is the order given; in the second they repeat sequences in reverse order. This outcome measure takes the total correct responses in reverse order. Sequence lengths are between two and seven digits, with to sequences of each length, giving a maximum score of 12.
  • Backward digit span score, change in score over one year [ Time Frame: From 30-90 days after stroke to one year after stroke ]
    The digit span test measures working memory and is taken from the Wechsler Adult Intelligence Scale IV. In the test participants must repeat a sequence of digits. Sequences are repeated at increasing length until the participant makes two errors at the same length. The test comprises two parts. In the first, participants repeat sequences is the order given; in the second they repeat sequences in reverse order. This outcome measure takes the total correct responses in reverse order. Sequence lengths are between two and seven digits, with to sequences of each length, giving a maximum score of 12.
  • Paired Associate Learning (PAL) recognition score at 30-90 days [ Time Frame: 30-90 days after stroke. ]
    The PAL task measures participants' ability to associate two items of information in memory. In this study, participants must learn a set of ten objects and their associated locations. The recognition score is the number of correct choices when given two possible locations for a given object. Each object is tested three times, giving a maximum score of 30.
  • Paired Associate Learning (PAL) recognition score at one year [ Time Frame: One year after stroke. ]
    The PAL task measures participants' ability to associate two items of information in memory. In this study, participants must learn a set of ten objects and their associated locations. The recognition score is the number of correct choices when given two possible locations for a given object. Each object is tested three times, giving a maximum score of 30.
  • Paired Associate Learning (PAL) recognition score, change in score over one year [ Time Frame: From 30-90 days after stroke to one year after stroke ]
    The PAL task measures participants' ability to associate two items of information in memory. In this study, participants must learn a set of ten objects and their associated locations. The recognition score is the number of correct choices when given two possible locations for a given object. Each object is tested three times, giving a maximum score of 30.
  • Paired Associate Learning (PAL) recall score at 30-90 days [ Time Frame: 30-90 days after stroke ]
    The PAL task measures participants' ability to associate two items of information in memory. In this study, participants must learn a set of ten objects and their associated locations. The recall score measures participants ability to recall which object was present at each location (a maximum of 10).
  • Paired Associate Learning (PAL) recall score at one year [ Time Frame: One year after stroke ]
    The PAL task measures participants' ability to associate two items of information in memory. In this study, participants must learn a set of ten objects and their associated locations. The recall score measures participants ability to recall which object was present at each location (a maximum of 10).
  • Paired Associate Learning (PAL) recall score, change in score over one year [ Time Frame: From 30-90 days after stroke to one year after stroke ]
    The PAL task measures participants' ability to associate two items of information in memory. In this study, participants must learn a set of ten objects and their associated locations. The recall score measures participants ability to recall which object was present at each location (a maximum of 10).
  • Process Dissociation Procedure (PDP) familiarity score at 30-90 days [ Time Frame: 30-90 days after stroke ]
    The PDP is a word memory test. Participants first read out loud a set of words. They are then presented with incomplete words and must fill in the missing letters. In one part of the test, participants must use one of the remembered words whenever possible. In the other part of the test, they must avoid the remembered words. The two parts are designed to dissociate two types of memory: familiarity and recollection. Familiarity is the unconscious remembering of a word because it was previously seen, which is an advantage when including the words, but a disadvantage when avoiding them. Recollection is the conscious remembering of a word and the context where it was encountered. This is an advantage in both parts of the test. The scores in each part of the test are combined to compute scores for familiarity and recollection, each in percent.
  • Process Dissociation Procedure (PDP) familiarity score at one year [ Time Frame: One year after stroke ]
    The PDP is a word memory test. Participants first read out loud a set of words. They are then presented with incomplete words and must fill in the missing letters. In one part of the test, participants must use one of the remembered words whenever possible. In the other part of the test, they must avoid the remembered words. The two parts are designed to dissociate two types of memory: familiarity and recollection. Familiarity is the unconscious remembering of a word because it was previously seen, which is an advantage when including the words, but a disadvantage when avoiding them. Recollection is the conscious remembering of a word and the context where it was encountered. This is an advantage in both parts of the test. The scores in each part of the test are combined to compute scores for familiarity and recollection, each in percent.
  • Process Dissociation Procedure (PDP) familiarity score, change in score over one year [ Time Frame: From 30-90 days after stroke to one year after stroke ]
    The PDP is a word memory test. Participants first read out loud a set of words. They are then presented with incomplete words and must fill in the missing letters. In one part of the test, participants must use one of the remembered words whenever possible. In the other part of the test, they must avoid the remembered words. The two parts are designed to dissociate two types of memory: familiarity and recollection. Familiarity is the unconscious remembering of a word because it was previously seen, which is an advantage when including the words, but a disadvantage when avoiding them. Recollection is the conscious remembering of a word and the context where it was encountered. This is an advantage in both parts of the test. The scores in each part of the test are combined to compute scores for familiarity and recollection, each in percent.
  • Process Dissociation Procedure (PDP) recollection score at 30-90 days [ Time Frame: 30-90 days after stroke ]
    The PDP is a word memory test. Participants first read out loud a set of words. They are then presented with incomplete words and must fill in the missing letters. In one part of the test, participants must use one of the remembered words whenever possible. In the other part of the test, they must avoid the remembered words. The two parts are designed to dissociate two types of memory: familiarity and recollection. Familiarity is the unconscious remembering of a word because it was previously seen, which is an advantage when including the words, but a disadvantage when avoiding them. Recollection is the conscious remembering of a word and the context where it was encountered. This is an advantage in both parts of the test. The scores in each part of the test are combined to compute scores for familiarity and recollection, each in percent.
  • Process Dissociation Procedure (PDP) recollection score at one year [ Time Frame: One year after stroke ]
    The PDP is a word memory test. Participants first read out loud a set of words. They are then presented with incomplete words and must fill in the missing letters. In one part of the test, participants must use one of the remembered words whenever possible. In the other part of the test, they must avoid the remembered words. The two parts are designed to dissociate two types of memory: familiarity and recollection. Familiarity is the unconscious remembering of a word because it was previously seen, which is an advantage when including the words, but a disadvantage when avoiding them. Recollection is the conscious remembering of a word and the context where it was encountered. This is an advantage in both parts of the test. The scores in each part of the test are combined to compute scores for familiarity and recollection, each in percent.
  • Process Dissociation Procedure (PDP) recollection score, change in score over one year [ Time Frame: From 30-90 days after stroke to one year after stroke ]
    The PDP is a word memory test. Participants first read out loud a set of words. They are then presented with incomplete words and must fill in the missing letters. In one part of the test, participants must use one of the remembered words whenever possible. In the other part of the test, they must avoid the remembered words. The two parts are designed to dissociate two types of memory: familiarity and recollection. Familiarity is the unconscious remembering of a word because it was previously seen, which is an advantage when including the words, but a disadvantage when avoiding them. Recollection is the conscious remembering of a word and the context where it was encountered. This is an advantage in both parts of the test. The scores in each part of the test are combined to compute scores for familiarity and recollection, each in percent.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title White Matter Connections and Memory: the STRATEGIC Study
Official Title White Matter Connections and Memory: the STRATEGIC Study
Brief Summary In patients who have had a stroke, memory problems are common. Some patients with memory problems improve over the first year after stroke, but recovery is unpredictable. The STRATEGIC study assesses patients with recent stroke and follows them up after one year. The study uses cognitive testing and advanced MRI to understand the brain's mechanism for recovery from memory problems and to identify factors that may predict later recovery.
Detailed Description

Memory breakdown in older age is a major challenge for medical research, with an increasing burden in personal, societal and fiscal terms. Stroke is an important cause. Memory depends on widespread networks in the brain which are bound together by white matter connections, which essentially act as the wiring of brain networks. This project uses a technique called diffusion tensor MRI to investigate these connections and their relationship to brain function and patterns of memory impairment after stroke.

Previous research showed that a tract called the fornix was most important in the healthy brain and in ageing. However, in individuals at an early stage of memory decline alternative pathways became disproportionately more important. This led to the idea that individuals with early memory decline might be especially vulnerable to injury to these alternative tracts from stroke. The purpose of this project is to test this idea.

The project focuses on patients with recent stroke. Participants undergo MRI, including diffusion tensor MRI, and in-depth testing of memory and other cognitive functions. The pattern of damage to temporal lobe connections in the brain will be assessed and related to the impact of brain infarction on memory. Analysis will determine how undamaged tracts contribute to recovery over one year. Finally, cutting edge computational image analysis techniques will be applied to try and predict memory profile in more detail and extract maximum information about prognosis from brain images.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood
Sampling Method Non-Probability Sample
Study Population Patients with recent ischaemic stroke.
Condition
  • Stroke
  • Cognitive Impairment
  • Memory Impairment
Intervention Not Provided
Study Groups/Cohorts Stroke patients
Patients with recent ischaemic stroke
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: June 7, 2019)
193
Original Actual Enrollment Same as current
Estimated Study Completion Date April 30, 2022
Actual Primary Completion Date June 7, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Aged over 50 years
  • Recent ischaemic stroke
  • English is first language

Exclusion Criteria:

  • Previous large artery infarct
  • Major neurological or psychiatric condition
  • Moderate to severe head injury (Mayo classification)
  • Dementia
  • Severe cardiac failure
  • Active malignancy
Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03982147
Other Study ID Numbers KCH14-072
13/LO/1745 ( Other Identifier: London Bromley Research Ethics Committee )
K022113 ( Other Grant/Funding Number: Medical Research Council, UK )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: If possible, we hope to share anonymised test scores and derived MRI measures, along with demographic and other background data.
Responsible Party Dr Mike O'Sullivan, King's College London
Study Sponsor King's College London
Collaborators Not Provided
Investigators
Principal Investigator: Michael J O'Sullivan, MBBS,PhD King's College London and University of Queensland
PRS Account King's College London
Verification Date June 2019