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Clinical Trials/NCT02779712
NCT02779712
Completed
Phase 2

Remote Ischaemic Conditioning After Stroke Trial (ReCAST-2): A Pilot Randomised Controlled Phase II Trial Evaluating Remote Ischaemic Conditioning (RIC) After Hyperacute Stroke 2

University of Nottingham2 sites in 1 country60 target enrollmentAugust 1, 2016
ConditionsStroke

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Stroke
Sponsor
University of Nottingham
Enrollment
60
Locations
2
Primary Endpoint
Trial feasibility
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2016
End Date
July 23, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Suspected clinical stroke with 6 hours of onset of neurological symptoms;
  • Written or witnessed oral consent, or relative/consultee advice.

Exclusion Criteria

  • Pre-morbid dependency mRS\>3;
  • 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);

Outcomes

Primary Outcomes

Trial feasibility

Time Frame: 90 days

Recruitment feasibility (recruitment rate)

Secondary Outcomes

  • Disability(Day 90±7)
  • Impairment(Day 4±1, day 90±7)
  • Dependency(Day 90±7)
  • Vascular Event Rate [Safety and Tolerability](Day 1, Day 4±1, day 90±7)
  • Mood(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)
  • Telephone cognition(Day 90±7)

Study Sites (2)

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