Remote Ischaemic Conditioning After Stroke Trial (ReCAST-2)

Phase 2

Completed

• Conditions: Stroke
• Interventions: Procedure: Remote ischaemic conditioning; Procedure: Sham

• Registration Number: NCT02779712
• Lead Sponsor: University of Nottingham

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-22
• Study First Submitted QC: 2016-05-18
• Study First Posted: 2016-05-20
• Study Start: 2016-08-01
• Status Verified: 2017-07
• Primary Completion: 2018-07-23
• Study Completion: 2018-07-23
• Last Update Submitted: 2018-10-10
• Last Update Posted: 2018-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remote Ischaemic Conditioning	Remote ischaemic conditioning	Remote 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	Control: 4 cycles of alternating 5 minutes inflation (up to 30 mmHg) followed by 5 minutes deflation of a standard upper arm blood pressure cuff

Primary Outcome Measures

Name	Time	Method
Trial feasibility	90 days	Recruitment feasibility (recruitment rate)

Secondary Outcome Measures

Name	Time	Method
Disability	Day 90±7	Barthel Index
Impairment	Day 4±1, day 90±7	National Institutes of Health Stroke Scale
Dependency	Day 90±7	Modified Rankin scale
Vascular Event Rate [Safety and Tolerability]	Day 1, Day 4±1, day 90±7	Number of participants with a vascular event (including limb ischaemia, recurrent stroke, myocardial infarction, venous thrombo-embolism)
Mood	Day 90±7	Zung depression scale
Treatment Related Serious Adverse Event Rates [Safety and Tolerability]	Day 1, Day 4±1, day 90±7	Number of participants with a serious adverse event related to treatment
Biomarkers	Immediately before RIC/sham at baseline; immediately after RIC/sham on Day 1; day 4±1	Plasma cytokines
Telephone cognition	Day 90±7	Modified Telephone Interview for Cognitive Status (TICS-M)

Trial Locations

Locations (2)

Derby Teaching Hospitals Foundation Trust; 🇬🇧 Derby, Derbyshire, United Kingdom

Nottingham University Hospitals NHS Trust; 🇬🇧 Nottingham, Nottinghamshire, United Kingdom