Remote Ischaemic Conditioning After Stroke Trial (ReCAST-2)
ReCAST-2
1 other identifier
interventional
60
1 country
2
Brief Summary
Stroke has an enormous impact on both individual and society. Novel treatments are required to relieve this burden and remote ischaemic conditioning (RIC) is one such approach. RIC refers to applying non-lethal ischaemia to an area distant from an organ you are trying to protect (e.g. the brain). Pre-clinical animal stroke studies have shown RIC to be neuroprotective and help restore functional outcome when compared to control. These outcomes are achieved simply by transiently occluding the blood supply to a limb (e.g. the arm) very soon after the stroke occurs. The mechanisms of protection are unclear but may be due enhancing the body's ability to protect itself from further injury by favorably altering cerebral blood flow or reducing the detrimental effects of oxygen free radicals. Ischaemic conditioning (IC) is an intervention already applied during cardiac surgery to protect the heart from damage and it may be effective after an acute myocardial infarction. The investigators therefore plan to conduct a pilot randomised controlled trial assessing the feasibility of applying RIC (4 cycles of blood pressure cuff inflation for 5 minutes) in patients within 6 hours of ischaemic stroke. The primary outcome is feasibility of RIC. Secondary outcomes include tolerability, safety and clinical efficacy. The results will inform the design of future trials of a potential intervention is that is pragmatic, non-invasive and simple to administer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 stroke
Started Aug 2016
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 22, 2016
CompletedFirst Posted
Study publicly available on registry
May 20, 2016
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 23, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 23, 2018
CompletedOctober 11, 2018
July 1, 2017
2 years
January 22, 2016
October 10, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Trial feasibility
Recruitment feasibility (recruitment rate)
90 days
Secondary Outcomes (10)
Vascular Event Rate [Safety and Tolerability]
Day 1, Day 4±1, day 90±7
Treatment Related Serious Adverse Event Rates [Safety and Tolerability]
Day 1, Day 4±1, day 90±7
Biomarkers
Immediately before RIC/sham at baseline; immediately after RIC/sham on Day 1; day 4±1
Biomarkers
Immediately before RIC/sham at baseline; immediately after RIC/sham on Day 1; day 4±1
Biomarkers
Immediately before RIC/sham at baseline; immediately after RIC/sham on Day 1; day 4±1
- +5 more secondary outcomes
Study Arms (2)
Remote Ischaemic Conditioning
ACTIVE COMPARATORRemote ischaemic conditioning (RIC group): 4 cycles of intermittent limb ischaemia - alternating 5 minutes inflation (20mmHg above systolic BP) followed by 5 minutes deflation of a standard upper arm blood pressure cuff
Control
SHAM COMPARATORControl: 4 cycles of alternating 5 minutes inflation (up to 30 mmHg) followed by 5 minutes deflation of a standard upper arm blood pressure cuff
Interventions
1 dose (=4 cycles) of intermittent upper limb ischaemia (1 cycle = 5minutes inflation to 20mmHg above systolic BP, 5 minutes deflation). Dose escalation: (i) Recruits 1-20 receive this cycle once (ii) Recruits 21-40 receive a second dose of 4-cycles one hour after the first. (iii) Recruits 41-60 receive further dosing, twice daily until day 4.
4 cycles of intermittent sham procedure (1 cycle = 5 minutes inflation to 30 mmHg, 5 minutes deflation), matching the dose escalation described in the intervention
Eligibility Criteria
You may qualify if:
- Suspected clinical stroke with 6 hours of onset of neurological symptoms;
- Age \>18;
- Written or witnessed oral consent, or relative/consultee advice.
You may not qualify if:
- Pre-morbid dependency mRS\>3;
- Dementia;
- Coma (GCS\< 8);
- Malignancy or significant co-morbidity thought to limit life expectancy to \<6 months;
- Blood sugar \< 3.5 mmol/L;
- Taking part in another clinical trial of an investigational medicinal product (CTIMP);
- Pregnancy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Derby Teaching Hospitals Foundation Trust
Derby, Derbyshire, DE22 3DT, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire, NG5 1PB, United Kingdom
Related Publications (1)
England TJ, Hedstrom A, O'Sullivan SE, Woodhouse L, Jackson B, Sprigg N, Bath PM. Remote Ischemic Conditioning After Stroke Trial 2: A Phase IIb Randomized Controlled Trial in Hyperacute Stroke. J Am Heart Assoc. 2019 Dec 3;8(23):e013572. doi: 10.1161/JAHA.119.013572. Epub 2019 Nov 21.
PMID: 31747864DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2016
First Posted
May 20, 2016
Study Start
August 1, 2016
Primary Completion
July 23, 2018
Study Completion
July 23, 2018
Last Updated
October 11, 2018
Record last verified: 2017-07