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出境医 / 临床实验 / Improved Prediction of Recurrent Stroke and Detection of Small Volume Stroke (ENCLOSE)

Improved Prediction of Recurrent Stroke and Detection of Small Volume Stroke (ENCLOSE)

Study Description
Brief Summary:

Rationale: Over 20.000 people suffer an ischemic stroke in the Netherlands each year. Large artery occlusions are easy to identify and can be treated with endovascular clot removal. 70% of patient will however suffer from a more distal occlusion resulting in small volume stroke or a transient ischemic attack (TIA). Small ischemic lesions are hard to detect with current acute stroke protocols. TIA and small volume stroke patients, are at an increased risk for recurrent stroke, making immediate diagnosis critical. Because thrombo-embolic sources often cause these strokes, identifying and treating the underlying aetiology has the potential to radically lower the risk of recurrence and improve the outcome of these patients.

Objectives: 1) To identify clinical and imaging predictors of recurrent stroke; 2) To improve early detection of small volume stroke with admission computed tomography perfusion (CTP) in patients with suspected acute ischemic stroke with small volume stroke or no ischemia on admission imaging.

Study design: Prospective, multicenter cohort study.

Study population: All patients who visited the University Medical Center (UMC) Utrecht, the Amsterdam University Medical Centers (Amsterdam UMC), location Academic Medical Center (AMC) or the St. Antonius Hospital and who underwent a CT-scan of the brain within 9 hours after onset of stroke symptoms with an age ≥18 years. Within 36 months, 720 patients will be enrolled in the study. Of these patients, 300 patients will be included for the follow-up magnetic resonance imaging (MRI).

Main study parameters/endpoints: The main study endpoints are: 1) Stroke recurrence rate at 2 years; 2) Presence and volume of acute ischemic lesions on follow-up diffusion weighted imaging MRI.


Condition or disease
Ischemic Stroke

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 720 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Improved Prediction of Recurrent Stroke and Detection of Small Volume Stroke
Actual Study Start Date : January 23, 2018
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Recurrent ischemic stroke [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Recurrent ischemic stroke [ Time Frame: 90 days ]
  2. modified Rankin scale [ Time Frame: 90 days ]

    The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death.

    0 - No symptoms.

    1. - No significant disability. Able to carry out all usual activities, despite some symptoms.
    2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
    3. - Moderate disability. Requires some help, but able to walk unassisted.
    4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
    5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
    6. - Dead.

    9 - No data.



Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients 18 years or older with acute stroke symptoms who visited the UMC Utrecht, the Amsterdam UMC, location AMC or the St. Antonius Hospital and who underwent a CT-scan within 9 hours after onset of stroke symptoms.
Criteria

Inclusion Criteria:

  • Age ≥18 years;
  • Time from symptom onset until imaging is <9 hours*;
  • Clinical diagnosis of acute ischemic stroke or TIA;
  • Informed consent from patient or family after the admission scan (unless the patient died).

    • Patients who awaken with stroke symptoms can only be included if they went to sleep without any stroke symptoms and the time from going to sleep until imaging is less than 9 hours.

Exclusion Criteria:

  • Patients with another diagnosis such as intracerebral hemorrhage, subarachnoid hemorrhage or tumor;
  • Patients with known contrast allergy or renal failure.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Frans Kauw, MD +3188-7571680 f.kauw-3@umcutrecht.nl

Locations
Layout table for location information
Netherlands
Amsterdam UMC, location AMC Not yet recruiting
Amsterdam, Noord-Holland, Netherlands, 1105 AZ
Contact: Valeria Guglielmi, MD    +3120-5664591    v.guglielmi@amsterdamumc.nl   
Principal Investigator: Charles B.L.M. Majoie, MD PhD         
Sub-Investigator: Valeria Guglielmi, MD         
Sub-Investigator: Jonathan M. Coutinho, MD PhD         
St. Antonius Hospital Not yet recruiting
Nieuwegein, Utrecht, Netherlands, 3435 CM
Contact: Wouter van Es, MD PhD    +3188-3208064    h.es@antoniusziekenhuis.nl   
Principal Investigator: Wouter van Es, MD PhD         
University Medical Center Utrecht Recruiting
Utrecht, Netherlands, 3584 CX
Contact: Frans Kauw, MD    +31 88 75 716 80    f.kauw-3@umcutrecht.nl   
Principal Investigator: Jan W Dankbaar, MD PhD         
Sub-Investigator: Frans Kauw, MD         
Sub-Investigator: Richard A.P. Takx, MD PhD         
Sponsors and Collaborators
UMC Utrecht
Dutch Heart Foundation
Netherlands Organisation for Scientific Research
Tracking Information
First Submitted Date July 10, 2019
First Posted Date July 15, 2019
Last Update Posted Date July 19, 2019
Actual Study Start Date January 23, 2018
Estimated Primary Completion Date March 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 10, 2019)
Recurrent ischemic stroke [ Time Frame: 2 years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 17, 2019)
  • Recurrent ischemic stroke [ Time Frame: 90 days ]
  • modified Rankin scale [ Time Frame: 90 days ]
    The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death. 0 - No symptoms.
    1. - No significant disability. Able to carry out all usual activities, despite some symptoms.
    2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
    3. - Moderate disability. Requires some help, but able to walk unassisted.
    4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
    5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
    6. - Dead.
    9 - No data.
Original Secondary Outcome Measures
 (submitted: July 10, 2019)
  • Recurrent ischemic stroke [ Time Frame: 90 days ]
  • modified Rankin scale [ Time Frame: 90 days ]
  • modified Rankin scale [ Time Frame: 2 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Improved Prediction of Recurrent Stroke and Detection of Small Volume Stroke
Official Title Improved Prediction of Recurrent Stroke and Detection of Small Volume Stroke
Brief Summary

Rationale: Over 20.000 people suffer an ischemic stroke in the Netherlands each year. Large artery occlusions are easy to identify and can be treated with endovascular clot removal. 70% of patient will however suffer from a more distal occlusion resulting in small volume stroke or a transient ischemic attack (TIA). Small ischemic lesions are hard to detect with current acute stroke protocols. TIA and small volume stroke patients, are at an increased risk for recurrent stroke, making immediate diagnosis critical. Because thrombo-embolic sources often cause these strokes, identifying and treating the underlying aetiology has the potential to radically lower the risk of recurrence and improve the outcome of these patients.

Objectives: 1) To identify clinical and imaging predictors of recurrent stroke; 2) To improve early detection of small volume stroke with admission computed tomography perfusion (CTP) in patients with suspected acute ischemic stroke with small volume stroke or no ischemia on admission imaging.

Study design: Prospective, multicenter cohort study.

Study population: All patients who visited the University Medical Center (UMC) Utrecht, the Amsterdam University Medical Centers (Amsterdam UMC), location Academic Medical Center (AMC) or the St. Antonius Hospital and who underwent a CT-scan of the brain within 9 hours after onset of stroke symptoms with an age ≥18 years. Within 36 months, 720 patients will be enrolled in the study. Of these patients, 300 patients will be included for the follow-up magnetic resonance imaging (MRI).

Main study parameters/endpoints: The main study endpoints are: 1) Stroke recurrence rate at 2 years; 2) Presence and volume of acute ischemic lesions on follow-up diffusion weighted imaging MRI.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients 18 years or older with acute stroke symptoms who visited the UMC Utrecht, the Amsterdam UMC, location AMC or the St. Antonius Hospital and who underwent a CT-scan within 9 hours after onset of stroke symptoms.
Condition Ischemic Stroke
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Kauw F, van Ommen F, Bennink E, Cramer MJ, Kappelle LJ, Takx RA, Velthuis BK, Viergever MA, Wouter van Es H, Schonewille WJ, Coutinho JM, Majoie CB, Marquering HA, de Jong HW, Dankbaar JW. Early detection of small volume stroke and thromboembolic sources with computed tomography: Rationale and design of the ENCLOSE study. Eur Stroke J. 2020 Dec;5(4):432-440. doi: 10.1177/2396987320966420. Epub 2020 Oct 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 10, 2019)
720
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2023
Estimated Primary Completion Date March 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Age ≥18 years;
  • Time from symptom onset until imaging is <9 hours*;
  • Clinical diagnosis of acute ischemic stroke or TIA;
  • Informed consent from patient or family after the admission scan (unless the patient died).

    • Patients who awaken with stroke symptoms can only be included if they went to sleep without any stroke symptoms and the time from going to sleep until imaging is less than 9 hours.

Exclusion Criteria:

  • Patients with another diagnosis such as intracerebral hemorrhage, subarachnoid hemorrhage or tumor;
  • Patients with known contrast allergy or renal failure.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Frans Kauw, MD +3188-7571680 f.kauw-3@umcutrecht.nl
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT04019483
Other Study ID Numbers NL62233.041.17
Has Data Monitoring Committee Yes
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: No
Responsible Party Jan. W. Dankbaar, MD, PhD, UMC Utrecht
Study Sponsor UMC Utrecht
Collaborators
  • Dutch Heart Foundation
  • Netherlands Organisation for Scientific Research
Investigators Not Provided
PRS Account UMC Utrecht
Verification Date July 2019