Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000987066
Ethics application status
Approved
Date submitted
29/10/2010
Date registered
16/11/2010
Date last updated
8/11/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
STroke imAging Prevention and Treatment (START): PrePARE Prediction and Prevention to Achieve optimal Recovery Endpoints after stroke
Scientific title
STroke imAging Prevention and Treatment (START): PrePARE Prediction and Prevention to Achieve optimal Recovery Endpoints after stroke
Secondary ID [1] 252755 0
Protocol No: NTA0902
Universal Trial Number (UTN)
Trial acronym
START_PrePARE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 258254 0
Depression 258255 0
Cognition 258256 0
Condition category
Condition code
Stroke 258448 258448 0 0
Ischaemic
Physical Medicine / Rehabilitation 258543 258543 0 0
Occupational therapy
Mental Health 258544 258544 0 0
Depression

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The START_PrePARE study is an observational cohort study that is part of the START program of study. In addition it will be linked as a sub-study of the START _EXTEND study, ACTRN: 12610000011088, which is a randomised, multicentre, double blinded, placebo controlled phase 3 trial within a larger cohort study of ischaemic stroke patients. Blood biomarkers, lesion location, and diet and lifestyle factors will be investigated in relation to post-stroke depression and functional outcome in the total START cohort, including START-EXTEND (up to n = 200). In START-PrePARE we will investigate the relationship between advanced imaging (resting state activity, cortical thickness and fibre tract integrity) and functional outcome and depression over time in a cohort of 100 patients. Assessments will include:

Biomarker (blood sample) collection at baseline, Day3, 3 months and 12 months;

Neurological and functional assessment at Day 3-7, 3 months and 12 months: NIHSS, mRS and BI;

Cognition at Day 3-7, 3 months and 12 months: Montreal Cognitive Assessment;

Diet and Lifestyle questionnaires at Day 3-7, 3 months and 12 months: Cancer Council of Victoria diet questionnaire, Rapid Assessment of Physical Activity questionnaire;

Depression at Day 3-7, 3 months and 12 months; (Montgomery-Asberg Depression Rating Scale with non-verbal supports if necessary);

Advanced brain imaging at 3 and 12 months;

Functional status at 3 and 12 months: Cognition (Mini Mental State Examination, Trails-B, Digit span, Shape Cancellation Task, Raven Colored Progressive Matrices, Stroop test), and Sensorimotor (Action Research Arm Test, Tactile Discrimination Test, Timed up and go test);

Participation at 3 and 12 months: Activity Card Sort-Aus

Quality of Life at 3 and 12 months: Stroke Impact Scale and Work and Social Adjustment Scale;

Mortality and recurrent stroke at 3 and 12 months.
Intervention code [1] 257271 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259282 0
Functional and structural changes in the brain: i.e cortical thickness, fibre tract connection and functional resting-state connections.
Timepoint [1] 259282 0
3 and 12 months
Primary outcome [2] 259283 0
Depression (Montgomery-Asberg Depression Rating Scale with non-verbal supports)
Timepoint [2] 259283 0
3 and 12 months
Primary outcome [3] 259284 0
Functional status: Functional Independence (mRS), Cognition (MoCA, MMSE, Trails-B, Digit span, Shape Cancellation Task, RCPM, Stroop test), and Sensorimotor (Action Research Arm Test, Tactile Discrimination Test, Timed up and go test)
Timepoint [3] 259284 0
3 and 12 months
Secondary outcome [1] 265905 0
Participation (Activity Card Sort)
Timepoint [1] 265905 0
3 and 12 months
Secondary outcome [2] 265906 0
Quality of life (Stroke Impact Scale)
Timepoint [2] 265906 0
3 and 12 months
Secondary outcome [3] 265907 0
Mortality and recurrent stroke
Timepoint [3] 265907 0
3 and 12 months

Eligibility
Key inclusion criteria
1. Patients presenting with ischaemic stroke.
2. Patient, family member or legally responsible person depending on local ethics requirements has given informed consent for participation in the START_PrePARE study
3. Patient’s age is > 18 years.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients who are non-English speaking
2. Contraindication to MR imaging on 3Tesla scanner.
3. Pre-stroke MRS score of greater or equal to 2 (indicating previous disability)
4. Any terminal illness such that the patient would not be expected to survive more than 1 year.
5. Pregnant women (clinically evident)

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/06/2010
Actual
21/06/2010
Date of last participant enrolment
Anticipated
Actual
13/04/2015
Date of last data collection
Anticipated
Actual
13/04/2015
Sample size
Target
100
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2153 0
Western Hospital - Footscray
Recruitment hospital [2] 2154 0
Epworth Richmond - Richmond
Recruitment hospital [3] 6899 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [4] 6900 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [5] 6901 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 7828 0
3011 - Footscray
Recruitment postcode(s) [2] 7829 0
3121 - Richmond
Recruitment postcode(s) [3] 14567 0
3050 - Parkville
Recruitment postcode(s) [4] 14568 0
3084 - Heidelberg
Recruitment postcode(s) [5] 14569 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 257816 0
Government body
Name [1] 257816 0
Commonwealth Scientific and Industrial Research Organisations (CSIRO)
Country [1] 257816 0
Australia
Primary sponsor type
Other Collaborative groups
Name
National Stroke Research Institute (NSRI)
Address
Melbourne Brain Centre, 245 Burgundy Street, Heidelberg, Victoria, 3084
Country
Australia
Secondary sponsor category [1] 257020 0
None
Name [1] 257020 0
Address [1] 257020 0
Country [1] 257020 0
Other collaborator category [1] 251551 0
Other Collaborative groups
Name [1] 251551 0
Brain Research Institute
Address [1] 251551 0
Melbourne Brain Centre, 245 Burgundy Street, Heidelberg, 3084
Country [1] 251551 0
Australia
Other collaborator category [2] 251552 0
University
Name [2] 251552 0
University of Melbourne
Address [2] 251552 0
The University of Melbourne
Grattan Street
Victoria 3010
Country [2] 251552 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259840 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 259840 0
Ethics committee country [1] 259840 0
Australia
Date submitted for ethics approval [1] 259840 0
Approval date [1] 259840 0
13/01/2010
Ethics approval number [1] 259840 0
2009.079
Ethics committee name [2] 259841 0
Austin Health Human Research Ethics Committee
Ethics committee address [2] 259841 0
Ethics committee country [2] 259841 0
Australia
Date submitted for ethics approval [2] 259841 0
Approval date [2] 259841 0
06/01/2010
Ethics approval number [2] 259841 0
H2010/03588
Ethics committee name [3] 296283 0
Epworth HealthCare Human Research and Ethics Committee
Ethics committee address [3] 296283 0
Ethics committee country [3] 296283 0
Australia
Date submitted for ethics approval [3] 296283 0
Approval date [3] 296283 0
25/07/2012
Ethics approval number [3] 296283 0
54812
Ethics committee name [4] 296284 0
La Trobe University Human Ethics Committee
Ethics committee address [4] 296284 0
Ethics committee country [4] 296284 0
Australia
Date submitted for ethics approval [4] 296284 0
Approval date [4] 296284 0
19/09/2010
Ethics approval number [4] 296284 0
10-071
Ethics committee name [5] 296285 0
Monash Medical Centre, Southern Health Research Governance
Ethics committee address [5] 296285 0
Ethics committee country [5] 296285 0
Australia
Date submitted for ethics approval [5] 296285 0
Approval date [5] 296285 0
14/12/2010
Ethics approval number [5] 296285 0
HREC/10/MH/76 SSA/10/SHB/22
Ethics committee name [6] 296286 0
Western Health Office for Research
Ethics committee address [6] 296286 0
Ethics committee country [6] 296286 0
Australia
Date submitted for ethics approval [6] 296286 0
Approval date [6] 296286 0
28/02/2011
Ethics approval number [6] 296286 0
HREC/10/MH/76 2009.079

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31689 0
Prof Leeanne Carey
Address 31689 0
Melbourne Brain Centre, 245 Burgundy Street, Heidelberg, Vic, 3084
Country 31689 0
Australia
Phone 31689 0
+61 3 9035 7088
Fax 31689 0
Email 31689 0
[email protected]
Contact person for public queries
Name 14936 0
Elise Cowley
Address 14936 0
Melbourne Brain Centre, 245 Burgundy Street, Heidelberg, 3084
Country 14936 0
Australia
Phone 14936 0
+61 3 90357232
Fax 14936 0
+61 3 9496 2881
Email 14936 0
[email protected]
Contact person for scientific queries
Name 5864 0
Leeanne Carey
Address 5864 0
Melbourne Brain Centre, 245 Burgundy Street, Heidelberg, 3084
Country 5864 0
Australia
Phone 5864 0
+61 3 90357088
Fax 5864 0
+61 3 90357303
Email 5864 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseComparing Participation Outcome Over Time Across International Stroke Cohorts: Outcomes and Methods.2019https://dx.doi.org/10.1016/j.apmr.2019.05.025
EmbaseLongitudinal changes in activity participation in the first year post-stroke and association with depressive symptoms.2019https://dx.doi.org/10.1080/09638288.2018.1471742
N.B. These documents automatically identified may not have been verified by the study sponsor.