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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
Gender
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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)
Address [1] 257816 0
Locked Bag 10
Clayton South VIC 3169
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
Office for Research
Level 6 East, Main Building
The Royal Melbourne Hospital
300 Grattan St
Parkville
Victoria 3050
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
Henry Buck Building
Austin Hospital
145 Studley Road
Heidelberg
Victoria, 3084
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
Bridge Road,
Richmind 3121
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
Bundoora, 3086
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
246 Clayton Road,
Clayton 3168
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
Furlong Rd,
St Albans, 3021
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
Stroke and depression are two of the highest ranked diseases in the Burden of Disease rankings of the World Health Organisation. Depression is a common sequela of stroke, with recent estimates between 30-60% of all stroke patients. Depression after stroke is often under diagnosed despite the fact that effective treatment exists. Good predictors of depression that could be used to identify ‘at risk’ patients early as part of the clinical care pathway for stroke currently do not exist.

This study aims to investigate the association between poststroke depression and 1) novel imaging markers of brain structure and function as identified by specialized MRI, and 2)functional outcomes including cognition, mood, sensorimotor function, and participation in daily activities.

START-PrePARE 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 (NTA 0901), which is a randomised, multicentre, double blinded, placebo controlled phase 3 trial within a larger cohort study of ischaemic stroke patients. START-PrePARE will comprise 100 patients. Participants consented onto the START-PrePARE study will be seen at their hospital at baseline, Day 3-7, 3 months and 12 months for collection of bloods and a series of research tests investigating mood, thinking ability (cognition), diet and lifestyle. The patients will also travel to a central site in Melbourne (the Melbourne Brain Centre), at 3 month and 12 month time points. Here advanced MR imaging, plus more advanced clinical measures of mood, cognition, sensori-motor function and participation will be performed. Investigators and patients will remain blinded to START-EXTEND treatment designation.

At Baseline a blood sample will be taken, two brief neurological assessments will be conducted and a medical history will be obtained. 3-7 days following stroke, participants will have another blood test, one brief neurological assessment and three questionnaires conducted asking about their diet and lifestyle and their mood and cognition. At the 3 month and 12 month visits participants will have specialised brain MRI scans which will approximately take 40 minutes plus set up time. They will also be given 10 short assessment tasks and three questionnaires to measure functional outcomes including cognition, mood, and movement as well as participation in household, leisure and social activities and quality of life. These assessments will be administered by a qualified therapist, and will take approximately 120 minutes. The blood test and neurological assessments will be conducted at hospital and the 10 short tasks will be conducted at the Melbourne Brain Centre or at the participant's place of residence if more convenient.

All information collected will be recorded without any identifying information and kept private and confidential.

An independent Data Safety Monitoring Committee has been set up to monitor safety for START-PrePARE patients for the duration of the trial.
Trial website
www.csiro.start.com
Trial related presentations / publications
Ma H, Parsons MW, Christensen S, Campbell BCV, Churilov L, Connelly A, et al. (2012)A multicentre, randomized, double-blinded, placebo-controlled Phase III study to investigate EXtending the time for Thrombolysis in Emergency Neurological Deficits (EXTEND). Int J Stroke 7, 74-80
Tse, T., Douglas, J., Lentin, P., Linden, T., Churilov, L., & Carey, L. M. (2014). Reduced activity participation 3 months after stroke associated with increased levels of depressive symptoms and stroke severity: An observational cohort study. Paper presented at the Stroke Society of Australasia 25th ASM, Hamilton Island, 30th July – 1st August. Int J Stroke 2014:9(Supp 1)21. doi:10.111/ijs.12297
Yusoff, S. Z. B., Tse, T., Carey, L. M. (2015). Factors impacting Quality of Life in stroke survivors at 3 and 12 months post-stroke: A longitudinal study of an Australian stroke cohort. International Journal of Stroke, 10(Suppl 3): 29-29.
Carey, L. M., Crewther, S., Salvado, O., Linden, T., Connelly, A., Wilson, W., Tse, T et al. (2015). STroke imAging pRevention and treatment (START): A longitudinal stroke cohort study: Clinical trials protocol. International Journal of Stroke, 10(4), 636-644. doi: 10.1111/ijs.12190
Palmer SM, Crewther SG, Carey LM and The START Project Team (2015) A meta-analysis of changes in brain activity in clinical depression. Front. Hum. Neurosci. 8:1045. doi: 10.3389/fnhum.2014.01045
Nguyen, V. A., Carey, L. C., Giummarra, L., Faou, P., Cooke, I., Howells, D. W., Tse, T., Macaulay, L., Ma, H., Davis, S. M., Donnan, G. A., Crewther, S. G. (accepted 23/05/2016). A Pathway Proteomic Profile of Ischemic Stroke Survivors Reveals Innate Immune Dysfunction in Association with Mild Symptoms of Depression - A Pilot Study. Frontiers in Neurology.
Tse, T. and L. M. Carey (2016). Longitudinal changes in activity participation after mild stroke. Asia Pacific Stroke Conference combined with Stroke Society of Australasia. Brisbane, Queensland, Australia, Cerebrovascular Diseases.
Tse, T. and L. M. Carey (2016). The Activity Card Sort – Australia: Validation and reliability in an Australian stroke cohort. Asia Pacific Stroke Conference combined with Stroke Society of Australasia. Brisbane, Queensland, Australia, Cerebrovascular Diseases.
Nguyen, V. A., Carey, L. C., Giummarra, L,. Faou, P., Cooke, I., Howells, D. W., Tse, T., Macaulay, L., Ma, H., Davis, S. M., Donnan, G. A., Crewther, S. G. (2016). A Pathway Proteomic Profile of Ischemic Stroke Survivors Reveals Innate Immune Dysfunction in Association with Mild Symptoms of Depression - A Pilot Study. Asia Pacific Stroke Conference combined with Stroke Society of Australasia. Brisbane, Queensland, Australia, Cerebrovascular Disease
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
Leeanne.carey@florey.edu.au
Contact person for public queries
Name 14936 0
Ms 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
ecowley@neurotrialsaustralia.com
Contact person for scientific queries
Name 5864 0
Prof 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
Leeanne.carey@florey.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary