Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000630516
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
Type of registration
Prospectively registered

Titles & IDs
Public title
Post-Reperfusion Pathophysiology in Acute Ischemic Stroke Part 2
Scientific title
Post-Reperfusion Pathophysiology in Acute Ischemic Stroke Part in Adult Patients 2
Secondary ID [1] 311974 0
none
Universal Trial Number (UTN)
Trial acronym
PRAISE II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 333582 0
Condition category
Condition code
Stroke 330264 330264 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 and blood tests with follow-up period up to 12 months (performed at MRI at 2-hours post-treatment, 24-72hours, 3 months & 12 months and blood tests at baseline, 2-hour and 24-72hours post-treatment ) as determined by participant's consent to continue attending MRIs.
Intervention code [1] 328441 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338049 0
MRI perfusion metrics assessed as composite primary outcome (e.g. Cerebral Blood Volume, Cerebral Blood Flow, Blood Brain Barrier Permeability)
Timepoint [1] 338049 0
Immediately post-treatment, 24-48 hrs, 3 months
Secondary outcome [1] 434305 0
Modified Rankin Scale
Timepoint [1] 434305 0
3-month post-treatment
Secondary outcome [2] 434306 0
Multimodal MRI metrics - Diffusion, QSM as composite secondary outcome
Timepoint [2] 434306 0
Immediately post-treatment, 24-48 hrs, 3 months
Secondary outcome [3] 434307 0
Blood biomarkers of stroke-related pathology as a composite secondary outcome (e.g. IL6, TNF)
Timepoint [3] 434307 0
immediately pre and post-treatment

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
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2024
Actual
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 316301 0
Government body
Name [1] 316301 0
NHMRC
Country [1] 316301 0
Australia
Funding source category [2] 316352 0
Hospital
Name [2] 316352 0
RMH Neuroscience Foundation
Country [2] 316352 0
Australia
Funding source category [3] 316353 0
Hospital
Name [3] 316353 0
Austin Medical Research Foundation
Country [3] 316353 0
Australia
Funding source category [4] 316355 0
Charities/Societies/Foundations
Name [4] 316355 0
Heart Foundation
Country [4] 316355 0
Australia
Primary sponsor type
Hospital
Name
Melbourne Health
Address
Country
Australia
Secondary sponsor category [1] 318538 0
None
Name [1] 318538 0
Address [1] 318538 0
Country [1] 318538 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315120 0
The Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 315120 0
https://www.thermh.org.au/research/researchers/ethics
Ethics committee country [1] 315120 0
Australia
Date submitted for ethics approval [1] 315120 0
Approval date [1] 315120 0
27/08/2018
Ethics approval number [1] 315120 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 133730 0
Dr Felix Ng
Address 133730 0
300 Grattan Street, Royal Melbourne Hospital, Parkville VIC 3050
Country 133730 0
Australia
Phone 133730 0
+613 9342 4424
Fax 133730 0
Email 133730 0
ng.f@unimelb.edu.au
Contact person for public queries
Name 133731 0
Felix Ng
Address 133731 0
300 Grattan Street, Royal Melbourne Hospital, Parkville VIC 3050
Country 133731 0
Australia
Phone 133731 0
+61 3 93427000
Fax 133731 0
Email 133731 0
ng.f@unimelb.edu.au
Contact person for scientific queries
Name 133732 0
Felix Ng
Address 133732 0
300 Grattan Street, Royal Melbourne Hospital, Parkville VIC 3050
Country 133732 0
Australia
Phone 133732 0
+61 3 93427000
Fax 133732 0
Email 133732 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.