ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

Protocol No: NTA0902

Universal Trial Number (UTN)

Trial acronym

START_PrePARE

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Stroke

Depression

Cognition

Condition category

Condition code

Stroke

Ischaemic

Physical Medicine / Rehabilitation

Occupational therapy

Mental Health

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]

Not applicable

Comparator / control treatment

Not applicable

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Functional and structural changes in the brain: i.e cortical thickness, fibre tract connection and functional resting-state connections.

Timepoint [1]

3 and 12 months

Primary outcome [2]

Depression (Montgomery-Asberg Depression Rating Scale with non-verbal supports)

Timepoint [2]

3 and 12 months

Primary outcome [3]

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]

3 and 12 months

Secondary outcome [1]

Participation (Activity Card Sort)

Timepoint [1]

3 and 12 months

Secondary outcome [2]

Quality of life (Stroke Impact Scale)

Timepoint [2]

3 and 12 months

Secondary outcome [3]

Mortality and recurrent stroke

Timepoint [3]

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?

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]

Western Hospital - Footscray

Recruitment hospital [2]

Epworth Richmond - Richmond

Recruitment hospital [3]

Royal Melbourne Hospital - City campus - Parkville

Recruitment hospital [4]

Austin Health - Austin Hospital - Heidelberg

Recruitment hospital [5]

Monash Medical Centre - Clayton campus - Clayton

Recruitment postcode(s) [1]

3011 - Footscray

Recruitment postcode(s) [2]

3121 - Richmond

Recruitment postcode(s) [3]

3050 - Parkville

Recruitment postcode(s) [4]

3084 - Heidelberg

Recruitment postcode(s) [5]

3168 - Clayton

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Commonwealth Scientific and Industrial Research Organisations (CSIRO)

Address [1]

Locked Bag 10
Clayton South VIC 3169

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Other Collaborative groups

Name [1]

Brain Research Institute

Address [1]

Melbourne Brain Centre, 245 Burgundy Street, Heidelberg, 3084

Country [1]

Australia

Other collaborator category [2]

University

Name [2]

University of Melbourne

Address [2]

The University of Melbourne
Grattan Street
Victoria 3010

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Melbourne Health Human Research Ethics Committee

Ethics committee address [1]

Office for Research
Level 6 East, Main Building
The Royal Melbourne Hospital
300 Grattan St
Parkville
Victoria 3050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

13/01/2010

Ethics approval number [1]

2009.079

Ethics committee name [2]

Austin Health Human Research Ethics Committee

Ethics committee address [2]

Henry Buck Building 
Austin Hospital
145 Studley Road
Heidelberg
Victoria, 3084

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

06/01/2010

Ethics approval number [2]

H2010/03588

Ethics committee name [3]

Epworth HealthCare Human Research and Ethics Committee

Ethics committee address [3]

Bridge Road,
Richmind 3121

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

Approval date [3]

25/07/2012

Ethics approval number [3]

54812

Ethics committee name [4]

La Trobe University Human Ethics Committee

Ethics committee address [4]

Bundoora, 3086

Ethics committee country [4]

Australia

Date submitted for ethics approval [4]

Approval date [4]

19/09/2010

Ethics approval number [4]

10-071

Ethics committee name [5]

Monash Medical Centre, Southern Health Research Governance

Ethics committee address [5]

246 Clayton Road,
Clayton 3168

Ethics committee country [5]

Australia

Date submitted for ethics approval [5]

Approval date [5]

14/12/2010

Ethics approval number [5]

HREC/10/MH/76 SSA/10/SHB/22

Ethics committee name [6]

Western Health Office for Research

Ethics committee address [6]

Furlong Rd, 
St Albans, 3021

Ethics committee country [6]

Australia

Date submitted for ethics approval [6]

Approval date [6]

28/02/2011

Ethics approval number [6]

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

Prof Leeanne Carey

Address

Melbourne Brain Centre, 245 Burgundy Street, Heidelberg, Vic, 3084

Country

Australia

Phone

+61 3 9035 7088

Fax

Leeanne.carey@florey.edu.au

Contact person for public queries

Name

Elise Cowley

Address

Melbourne Brain Centre, 245 Burgundy Street, Heidelberg, 3084

Country

Australia

Phone

+61 3 90357232

Fax

+61 3 9496 2881

ecowley@neurotrialsaustralia.com

Contact person for scientific queries

Name

Leeanne Carey

Address

Melbourne Brain Centre, 245 Burgundy Street, Heidelberg, 3084

Country

Australia

Phone

+61 3 90357088

Fax

+61 3 90357303

Leeanne.carey@florey.edu.au

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

Source	Title	Year of Publication	DOI
Embase	Comparing Participation Outcome Over Time Across International Stroke Cohorts: Outcomes and Methods.	2019	https://dx.doi.org/10.1016/j.apmr.2019.05.025
Embase	Longitudinal changes in activity participation in the first year post-stroke and association with depressive symptoms.	2019	https://dx.doi.org/10.1080/09638288.2018.1471742

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically