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出境医 / 临床实验 / Recovery and Outcomes From Stroke (ROSE)

Recovery and Outcomes From Stroke (ROSE)

Study Description
Brief Summary:
The investigators will perform follow-up on 500 cases of deep and lobar intracerebral hemorrhage to perform advanced neuroimaging before 45 days post stroke, and evaluations of motor and cognitive function at baseline, 3 months and 6 months to determine predictors of recovery, progressive cognitive or functional impairment.

Condition or disease
Intracerebral Hemorrhage

Detailed Description:

Stroke is the third leading cause of death and the leading cause of adult disability in the United States. More adults are affected by stroke each year than Alzheimer's disease, multiple sclerosis, amyotrophic lateral sclerosis or Parkinson's disease. Hemorrhagic strokes represent the most severe subtypes of stroke. An estimated 40-50% of hemorrhagic stroke victims will die and more than 80% of survivors remain disabled after hemorrhagic stroke. Yet the vast majority of analyses on outcome after stroke have focused principally on gross measures of functional outcome.

Furthermore hemorrhagic stroke differs from ischemic stroke where a loss of blood causes the area affected to be readily visible on scanning. But with hemorrhagic stroke, not only the area that we can directly see, but nearby tracts that have been compressed or stretched by the mass of the hemorrhage can be injured.

The investigators propose to follow-up on 500 cases of deep and lobar ICH to perform serial evaluations of motor and cognitive function and advanced neuroimaging to determine predictors of recovery, progressive cognitive or functional impairment. Our proposal has the advantages of adding onto a prospective ICH study which will identify and recruit cases, ability to evaluate for the degree and impact of survival and severity biases, baseline neuroimaging which includes baseline MRI, biologic samples including genotyping for apolipoprotein E alleles and uniform phenotype definitions as well as expertise in recovery/outcome analyses, advanced neuroimaging processes and epidemiologic study. This proposal performs detailed cognitive, motor and functional assessments on cases of intracerebral hemorrhage and correlates with tractography imaging. The investigators hypothesize that unlike ischemic stroke, the mass effect of the hemorrhage itself may disrupt nearby tracts in some patients while preserving them in others and will serve as a better predictor of who may recover after ICH. This project will represent the largest number of ICH cases in which tractography imaging has been performed to date.

Specific Aim #1: Improve motor recovery prediction after supratentorial ICH by adding proportion of tract injury as measured by diffusion tensor imaging (DTI) independent of the ICH volume, location, age, gender and intraventricular hemorrhage (IVH).

Hypothesis #1a: Increasing severity of injury to corticospinal tracts in ICH patients will predict worse specific motor deficits assessed at 3-month and 6-month post-stroke.

Hypothesis #1b. Injury to cortical-cortical tracts including the superior longitudinal fasciculus, uncinate fasciculus, cingulum, and arcuate fasciculus, will predict greater impairment in corresponding cognitive domains including attention, memory, executive function, and language function assessed at 3 and 6-month post-stroke.

Specific Aim #2: Determine the association of periventricular tract injury in intraventricular hemorrhage complicating ICH with subsequent incontinence and gait ataxia.

Hypothesis #2: Patients with IVH will be associated with greater periventricular tract injury than patients without IVH and that this injury will be independently associated with long-term neurogenic incontinence and gait instability after controlling for severity of the ICH including location and volume, age and gender.

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Recovery and Outcomes From Stroke (ROSE) Sub-study of Genetic and Environmental Risk Factors for Hemorrhagic Stroke
Actual Study Start Date : August 23, 2017
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022
Arms and Interventions
Group/Cohort
1
Participants who have had a hemorrhagic stroke and have been enrolled into the Genetic and Environmental Risk Factors for Hemorrhagic Stroke Study who live in the area of University of Cincinnati, Massachusetts General Hospital, University of Maryland, Duke University, Columbia University and University of Chicago Illinois, age 18 years or greater. Ability of participant or legal representative to provide informed consent. Racial/ethnic category of Caucasian, African American or Hispanic.
Outcome Measures
Primary Outcome Measures :
  1. Change motor recovery prediction after supratentorial intracerebral hemorrhage(ICH) [ Time Frame: Ongoing/completed end of August 2020 ]
    This measure will determined by adding proportion of tract injury as measured by diffusion tensor imaging(DTI) methods. Measures are independent of the presenting Glasgow Coma Scale(GCS),ICH volume,location,age,sex and intraventricular hemorrhage (IVH).The primary outcome measure will be the global motor score from the motor assessment scale(MAS) testing which includes eight areas of assessment in eight areas of motor function.The MAS evaluates performance on functional tasks using a 7-point ordinal scale(0-6) in each of eight domains-moving from supine to side lying,supine to sitting over the edge of a bed, balanced sitting,moving from sitting to standing,walking,upper-arm function,hand movements(e.g., drawing a line),and advanced hand activities(e.g. combing the back of the head) rather than isolated movements. A score of 6 on each item, or an overall score of 48 indicates optimal motor behavior, and a lower score would indicate less than optimal motor behavior.


Secondary Outcome Measures :
  1. Determine the correlation of periventricular tract injury in intraventricular hemorrhage(IVH) complicating intracerebral hemorrhage (ICH) with subsequent incontinence. [ Time Frame: Ongoing/completed end of August 2020 ]
    Determine the correlation of periventricular tract injury in IVH complicating ICH as measured by diffusion tensor imaging (DTI) with subsequent incontinence as measured by the Urogenital Distress Inventory (UDI-6),a 6 question measure of urinary continence that is highly reliable.The UDI-6 assessment scoring includes item responses that are assigned values of 0 for "not at all," 1 for "slightly," 2 for "moderately," and 3 for "greatly."The average score of items responded to is calculated,which ranges from 0 to 3,is multiplied by 33 1/3 to put scores on a scale of 0 to 100.The lower score would indicate a better outcome and a higher score would indicate a worse outcome.

  2. Determine the correlation of periventricular tract injury in intraventricular hemorrhage(IVH) with complicating intracerebral (ICH) with subsequent gait ataxia. [ Time Frame: Ongoing/completed end of August 2020 ]
    Determine the correlation of periventricular tract injury in IVH complicating intracerebral(ICH) as measured by diffusion tensor imaging(DTI) with subsequent gait ataxia as measured by motor assessment scale(MAS).The MAS includes eight areas of assessment in eight areas of motor function and evaluates performance on functional tasks using a 7 point ordinal scale(0-6) in each of the eight domains:moving from supine to side lying,supine to sitting over the edge of a bed,balanced sitting,moving from sitting to standing,walking, upper-arm function,hand movements(e.g., drawing a line), and advanced hand activities(e.g. combing the back of the head)rather than isolated movements.A score of 6 on each item,or an overall score of 48 indicates optimal motor behavior,and a lower score would indicate less than optimal motor behavior.


Biospecimen Retention:   Samples With DNA
Whole Blood, DNA, RNA and complete blood count (CBC)

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:   Probability Sample
Study Population
Participants already enrolled in Genetic and Environmental Risk Factors for Hemorrhagic Stroke
Criteria

Inclusion Criteria:

  • Age 18 years or greater, fulfillment of the criteria for Deep, Subcortical or Lobar Intracerebral Hemorrhage (ICH)
  • No evidence of trauma, vascular malformation or aneurysm, or brain tumor as a cause of ICH.
  • Ability of the patient or legal representative to provide informed consent

Exclusion Criteria:

  • Brainstem or Cerebellar ICH
  • Patients Severely Affected by the ICH, Early Mortality, Hospice, or Withdraw of Care NOT eligible for ROSE
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Tyler P Behymer, BS 513-558-0122 Tyler.behymer@uc.edu
Contact: Lee A Gilkerson, RN,BSN 513-558-6140 Lee.gilkerson@uc.edu

Locations
Layout table for location information
United States, Illinois
University of Illinois Chicago Not yet recruiting
Chicago, Illinois, United States, 60612
Contact: Maureen Hillman    312-355-3863    hillmann@uic.edu   
Principal Investigator: Fernando Testai, M.D.         
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: Tiffany Watson    410-706-1902    tiwatson@som.umaryland.edu   
Principal Investigator: Steven Kittner, M.D.         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Christina Kourkoulis, BS    617-726-5358    CKOURKOULIS@PARTNERS.ORG   
Principal Investigator: Jonathan Rosand, M.D.         
United States, New York
Columbia University Not yet recruiting
New York, New York, United States, 10032
Contact: Angela Velazquez    212-305-6071    aqv2113@cumc.columbia.edu   
Principal Investigator: David Roh, M.D.         
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: Andreea Podgoreanu       andrea.podgoreanu@duke.edu   
Principal Investigator: Michael L James, M.D.         
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Tyler P Behymer, BS    513-558-0122    Tyler.behymer@uc.edu   
Contact: Lee A Gilkerson, RN,BSN    513-558-6140    Lee.gilkerson@uc.edu   
Principal Investigator: Daniel Woo, M.D.,MS         
Sponsors and Collaborators
University of Cincinnati
National Institute of Neurological Disorders and Stroke (NINDS)
Massachusetts General Hospital
University of Maryland, Baltimore
Duke University, Durham, NC
Columbia University
University of Illinois at Chicago
Investigators
Layout table for investigator information
Principal Investigator: Daniel Woo, MD, MS University of Cincinnati
Tracking Information
First Submitted Date June 11, 2019
First Posted Date July 5, 2019
Last Update Posted Date October 28, 2019
Actual Study Start Date August 23, 2017
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 24, 2019)
Change motor recovery prediction after supratentorial intracerebral hemorrhage(ICH) [ Time Frame: Ongoing/completed end of August 2020 ]
This measure will determined by adding proportion of tract injury as measured by diffusion tensor imaging(DTI) methods. Measures are independent of the presenting Glasgow Coma Scale(GCS),ICH volume,location,age,sex and intraventricular hemorrhage (IVH).The primary outcome measure will be the global motor score from the motor assessment scale(MAS) testing which includes eight areas of assessment in eight areas of motor function.The MAS evaluates performance on functional tasks using a 7-point ordinal scale(0-6) in each of eight domains-moving from supine to side lying,supine to sitting over the edge of a bed, balanced sitting,moving from sitting to standing,walking,upper-arm function,hand movements(e.g., drawing a line),and advanced hand activities(e.g. combing the back of the head) rather than isolated movements. A score of 6 on each item, or an overall score of 48 indicates optimal motor behavior, and a lower score would indicate less than optimal motor behavior.
Original Primary Outcome Measures
 (submitted: July 1, 2019)
Change motor recovery prediction after supratentorial ICH [ Time Frame: Ongoing to be completed at the end of August 2020 ]
Change motor recovery prediction after supratentorial ICH by adding proportion of tract injury as measured by DTI independent of the presenting Glasgow Coma Scale, ICH volume, location, age, sex and intraventricular hemorrhage.
Change History
Current Secondary Outcome Measures
 (submitted: October 24, 2019)
  • Determine the correlation of periventricular tract injury in intraventricular hemorrhage(IVH) complicating intracerebral hemorrhage (ICH) with subsequent incontinence. [ Time Frame: Ongoing/completed end of August 2020 ]
    Determine the correlation of periventricular tract injury in IVH complicating ICH as measured by diffusion tensor imaging (DTI) with subsequent incontinence as measured by the Urogenital Distress Inventory (UDI-6),a 6 question measure of urinary continence that is highly reliable.The UDI-6 assessment scoring includes item responses that are assigned values of 0 for "not at all," 1 for "slightly," 2 for "moderately," and 3 for "greatly."The average score of items responded to is calculated,which ranges from 0 to 3,is multiplied by 33 1/3 to put scores on a scale of 0 to 100.The lower score would indicate a better outcome and a higher score would indicate a worse outcome.
  • Determine the correlation of periventricular tract injury in intraventricular hemorrhage(IVH) with complicating intracerebral (ICH) with subsequent gait ataxia. [ Time Frame: Ongoing/completed end of August 2020 ]
    Determine the correlation of periventricular tract injury in IVH complicating intracerebral(ICH) as measured by diffusion tensor imaging(DTI) with subsequent gait ataxia as measured by motor assessment scale(MAS).The MAS includes eight areas of assessment in eight areas of motor function and evaluates performance on functional tasks using a 7 point ordinal scale(0-6) in each of the eight domains:moving from supine to side lying,supine to sitting over the edge of a bed,balanced sitting,moving from sitting to standing,walking, upper-arm function,hand movements(e.g., drawing a line), and advanced hand activities(e.g. combing the back of the head)rather than isolated movements.A score of 6 on each item,or an overall score of 48 indicates optimal motor behavior,and a lower score would indicate less than optimal motor behavior.
Original Secondary Outcome Measures
 (submitted: July 1, 2019)
  • Determine the correlation of periventricular tract injury in intraventricular hemorrhage with complicating ICH with subsequent incontinence. [ Time Frame: Ongoing to be completed at the end of August 2020 ]
    Determine the correlation of periventricular tract injury in intraventricular hemorrhage complicating ICH as measured by DTI with subsequent incontinence as measured by the Urogenital Distress Inventory (UDI-6).
  • Determine the correlation of periventricular tract injury in intraventricular hemorrhage with complicating ICH with subsequent gait ataxia. [ Time Frame: Ongoing to be completed at the end of August 2020 ]
    Determine the correlation of periventricular tract injury in intraventricular hemorrhage complicating ICH as measured by DTI with subsequent gait ataxia as measured by Motor Assessment Scale (MAS)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Recovery and Outcomes From Stroke
Official Title Recovery and Outcomes From Stroke (ROSE) Sub-study of Genetic and Environmental Risk Factors for Hemorrhagic Stroke
Brief Summary The investigators will perform follow-up on 500 cases of deep and lobar intracerebral hemorrhage to perform advanced neuroimaging before 45 days post stroke, and evaluations of motor and cognitive function at baseline, 3 months and 6 months to determine predictors of recovery, progressive cognitive or functional impairment.
Detailed Description

Stroke is the third leading cause of death and the leading cause of adult disability in the United States. More adults are affected by stroke each year than Alzheimer's disease, multiple sclerosis, amyotrophic lateral sclerosis or Parkinson's disease. Hemorrhagic strokes represent the most severe subtypes of stroke. An estimated 40-50% of hemorrhagic stroke victims will die and more than 80% of survivors remain disabled after hemorrhagic stroke. Yet the vast majority of analyses on outcome after stroke have focused principally on gross measures of functional outcome.

Furthermore hemorrhagic stroke differs from ischemic stroke where a loss of blood causes the area affected to be readily visible on scanning. But with hemorrhagic stroke, not only the area that we can directly see, but nearby tracts that have been compressed or stretched by the mass of the hemorrhage can be injured.

The investigators propose to follow-up on 500 cases of deep and lobar ICH to perform serial evaluations of motor and cognitive function and advanced neuroimaging to determine predictors of recovery, progressive cognitive or functional impairment. Our proposal has the advantages of adding onto a prospective ICH study which will identify and recruit cases, ability to evaluate for the degree and impact of survival and severity biases, baseline neuroimaging which includes baseline MRI, biologic samples including genotyping for apolipoprotein E alleles and uniform phenotype definitions as well as expertise in recovery/outcome analyses, advanced neuroimaging processes and epidemiologic study. This proposal performs detailed cognitive, motor and functional assessments on cases of intracerebral hemorrhage and correlates with tractography imaging. The investigators hypothesize that unlike ischemic stroke, the mass effect of the hemorrhage itself may disrupt nearby tracts in some patients while preserving them in others and will serve as a better predictor of who may recover after ICH. This project will represent the largest number of ICH cases in which tractography imaging has been performed to date.

Specific Aim #1: Improve motor recovery prediction after supratentorial ICH by adding proportion of tract injury as measured by diffusion tensor imaging (DTI) independent of the ICH volume, location, age, gender and intraventricular hemorrhage (IVH).

Hypothesis #1a: Increasing severity of injury to corticospinal tracts in ICH patients will predict worse specific motor deficits assessed at 3-month and 6-month post-stroke.

Hypothesis #1b. Injury to cortical-cortical tracts including the superior longitudinal fasciculus, uncinate fasciculus, cingulum, and arcuate fasciculus, will predict greater impairment in corresponding cognitive domains including attention, memory, executive function, and language function assessed at 3 and 6-month post-stroke.

Specific Aim #2: Determine the association of periventricular tract injury in intraventricular hemorrhage complicating ICH with subsequent incontinence and gait ataxia.

Hypothesis #2: Patients with IVH will be associated with greater periventricular tract injury than patients without IVH and that this injury will be independently associated with long-term neurogenic incontinence and gait instability after controlling for severity of the ICH including location and volume, age and gender.

Study Type Observational
Study Design Observational Model: Ecologic or Community
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole Blood, DNA, RNA and complete blood count (CBC)
Sampling Method Probability Sample
Study Population Participants already enrolled in Genetic and Environmental Risk Factors for Hemorrhagic Stroke
Condition Intracerebral Hemorrhage
Intervention Not Provided
Study Groups/Cohorts 1
Participants who have had a hemorrhagic stroke and have been enrolled into the Genetic and Environmental Risk Factors for Hemorrhagic Stroke Study who live in the area of University of Cincinnati, Massachusetts General Hospital, University of Maryland, Duke University, Columbia University and University of Chicago Illinois, age 18 years or greater. Ability of participant or legal representative to provide informed consent. Racial/ethnic category of Caucasian, African American or Hispanic.
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 Recruiting
Estimated Enrollment
 (submitted: July 1, 2019)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 2022
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Age 18 years or greater, fulfillment of the criteria for Deep, Subcortical or Lobar Intracerebral Hemorrhage (ICH)
  • No evidence of trauma, vascular malformation or aneurysm, or brain tumor as a cause of ICH.
  • Ability of the patient or legal representative to provide informed consent

Exclusion Criteria:

  • Brainstem or Cerebellar ICH
  • Patients Severely Affected by the ICH, Early Mortality, Hospice, or Withdraw of Care NOT eligible for ROSE
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Tyler P Behymer, BS 513-558-0122 Tyler.behymer@uc.edu
Contact: Lee A Gilkerson, RN,BSN 513-558-6140 Lee.gilkerson@uc.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04007757
Other Study ID Numbers NS036695-A1501
R01NS100417 ( U.S. NIH Grant/Contract )
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: No
Responsible Party Daniel Woo, University of Cincinnati
Study Sponsor University of Cincinnati
Collaborators
  • National Institute of Neurological Disorders and Stroke (NINDS)
  • Massachusetts General Hospital
  • University of Maryland, Baltimore
  • Duke University, Durham, NC
  • Columbia University
  • University of Illinois at Chicago
Investigators
Principal Investigator: Daniel Woo, MD, MS University of Cincinnati
PRS Account University of Cincinnati
Verification Date October 2019