Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000629538
Ethics application status
Approved
Date submitted
21/04/2024
Date registered
15/05/2024
Date last updated
15/05/2024
Date data sharing statement initially provided
15/05/2024
Date results information initially provided
15/05/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Post-Reperfusion Pathophysiology in Acute Ischemic Stroke
Scientific title
Post-Reperfusion Pathophysiology in Acute Ischemic Stroke in adult patients
Secondary ID [1] 312008 0
none
Universal Trial Number (UTN)
Trial acronym
PRAISE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 333617 0
Condition category
Condition code
Stroke 330305 330305 0 0
Ischaemic

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Adult patients (>18 years-old) presenting to the recruiting comprehensive stroke centres with acute stroke with anterior circulation large vessel occlusion considered for or receiving reperfusion therapies will be recruited for additional serial MRIs with follow-up period up to 12 months (performed at 2-hours treatment, 24-72hours, 3 months & 12 months) as determined by participant's consent to continue attending MRIs.
Intervention code [1] 328462 0
Diagnosis / Prognosis
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338050 0
MRI perfusion metrics assessed as composite primary outcome (e.g. Cerebral Blood Volume, Cerebral Blood Flow, Blood Brain Barrier Permeability)
Timepoint [1] 338050 0
<2hr post-treatment, 24-72hours, 3 months, 12 months
Secondary outcome [1] 434308 0
Modified Rankin Scale
Timepoint [1] 434308 0
3-month, 12-months
Secondary outcome [2] 434309 0
Multimodal MRI metrics as composite secondary outcome
(e.g. diffusion FA/MD/ADC)
Timepoint [2] 434309 0
<2hr post-treatment, 24-72hours, 3 months, 12 months

Eligibility
Key inclusion criteria
Adult patients (>18 years-old) presenting for or receiving reperfusion therapies (e.g. thrombectomy) for acute ischaemic stroke with anterior circulation large vessel occlusion.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusions include inability to give informed consent, contraindications to MRI study (eg. metallic foreign bodies in situ, claustrophobia, pregnancy), medical instability, terminal illness with expected survival less than 1 year.
Specific MRI sequences involving Gadolinum will be omitted for patients with significant renal impairment (eGFR <30 ml/min) as per standard practice for the studies.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
25/02/2019
Date of last participant enrolment
Anticipated
Actual
3/11/2022
Date of last data collection
Anticipated
Actual
22/03/2023
Sample size
Target
87
Accrual to date
Final
87
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 316356 0
Government body
Name [1] 316356 0
NHMRC
Country [1] 316356 0
Australia
Funding source category [2] 316357 0
Hospital
Name [2] 316357 0
RMH Neuroscience Foundation
Country [2] 316357 0
Australia
Funding source category [3] 316358 0
Hospital
Name [3] 316358 0
Austin Medical Research Foundation
Country [3] 316358 0
Australia
Primary sponsor type
Hospital
Name
Melbourne Health
Address
Country
Australia
Secondary sponsor category [1] 318540 0
None
Name [1] 318540 0
Address [1] 318540 0
Country [1] 318540 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315163 0
The Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 315163 0
https://www.thermh.org.au/research/researchers/ethics
Ethics committee country [1] 315163 0
Australia
Date submitted for ethics approval [1] 315163 0
23/07/2018
Approval date [1] 315163 0
27/08/2018
Ethics approval number [1] 315163 0

Summary
Brief summary
The study is an Australian multicentre prospective imaging study performing multiparametric MRIs after acute reperfusion treatment for anterior circulation large vessel occlusion with cerebral perfusion, microstructural, metabolic and functional assessment at multiple follow-up time points.
The project has received ethical approval from the Melbourne Health Human Research Ethics Committee (HREC). The HREC confirms that your proposal meets the requirements of the National Statement on Ethical Conduct in Human Research (2007). This HREC is organised and operates in accordance with the National Health and Medical Research Council’s (NHRMC) National Statement on Ethical Conduct in Human Research (2007), and all subsequent updates, and in accordance with the Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95), the Health Privacy Principles described in the Health Records Act 2001 (Vic) and Section 95A of the
Privacy Act 1988 (and subsequent Guidelines).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133870 0
Dr Felix Ng
Address 133870 0
300 Grattan Street, Royal Melbourne Hospital, Parkville, Victoria 3050
Country 133870 0
Australia
Phone 133870 0
+613 9342 4424
Fax 133870 0
Email 133870 0
ng.f@unimelb.edu.au
Contact person for public queries
Name 133871 0
Felix Ng
Address 133871 0
300 Grattan Street, Royal Melbourne Hospital, Parkville, Victoria 3050
Country 133871 0
Australia
Phone 133871 0
+61 3 93427000
Fax 133871 0
Email 133871 0
ng.f@unimelb.edu.au
Contact person for scientific queries
Name 133872 0
Felix Ng
Address 133872 0
300 Grattan Street, Royal Melbourne Hospital, Parkville 3050
Country 133872 0
Australia
Phone 133872 0
+61 93427000
Fax 133872 0
Email 133872 0
ng.f@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.