Clinical trial NCT02779712: Remote Ischaemic Conditioning After Stroke Trial (ReCAST-2)
Official title: Remote Ischaemic Conditioning After Stroke Trial (ReCAST-2): A Pilot Randomised Controlled Phase II Trial Evaluating Remote Ischaemic Conditioning (RIC) After Hyperacute Stroke 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stroke
Keywords: Remote ischaemic conditioning
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2016-05-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Suspected clinical stroke with 6 hours of onset of neurological symptoms;
2. Age \>18;
3. Written or witnessed oral consent, or relative/consultee advice.

Exclusion Criteria:

1. Pre-morbid dependency mRS\>3;
2. Dementia;
3. Coma (GCS\< 8);
4. Malignancy or significant co-morbidity thought to limit life expectancy to \<6 months;
5. Blood sugar \< 3.5 mmol/L;
6. Taking part in another clinical trial of an investigational medicinal product (CTIMP);
7. Pregnancy.

Primary outcomes:
measure: Trial feasibility
timeFrame: 90 days
Secondary outcomes:
measure: Vascular Event Rate [Safety and Tolerability]
timeFrame: Day 1, Day 4±1, day 90±7
measure: Treatment Related Serious Adverse Event Rates [Safety and Tolerability]
timeFrame: Day 1, Day 4±1, day 90±7
measure: Biomarkers
timeFrame: Immediately before RIC/sham at baseline; immediately after RIC/sham on Day 1; day 4±1
measure: Biomarkers
timeFrame: Immediately before RIC/sham at baseline; immediately after RIC/sham on Day 1; day 4±1
measure: Biomarkers
timeFrame: Immediately before RIC/sham at baseline; immediately after RIC/sham on Day 1; day 4±1
measure: Impairment
timeFrame: Day 4±1, day 90±7
measure: Dependency
timeFrame: Day 90±7
measure: Disability
timeFrame: Day 90±7
measure: Mood
timeFrame: Day 90±7
measure: Telephone cognition
timeFrame: Day 90±7
Other outcomes:
Locations:
city: Derby
country: United Kingdom
facility: Derby Teaching Hospitals Foundation Trust
state: Derbyshire
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
state: Nottinghamshire
Study officials:
References:
citation: 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.