Remote Ischaemic Conditioning After Stroke Trial (ReCAST-2)

Stroke Clinical 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02779712
• Other study ID #: 16007
• Status: Completed
• Phase: Phase 2
• Start date: August 1, 2016
• Est. completion date: July 23, 2018

Study information

• Verified date: July 2017
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 23, 2018
• Est. primary completion date: July 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Procedure:
• Remote ischaemic conditioning
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.
• Sham
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

Locations

Country	Name	City	State
United Kingdom	Derby Teaching Hospitals Foundation Trust	Derby	Derbyshire
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham	Nottinghamshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trial feasibility	Recruitment feasibility (recruitment rate)	90 days
Secondary	Vascular Event Rate [Safety and Tolerability]	Number of participants with a vascular event (including limb ischaemia, recurrent stroke, myocardial infarction, venous thrombo-embolism)	Day 1, Day 4±1, day 90±7
Secondary	Treatment Related Serious Adverse Event Rates [Safety and Tolerability]	Number of participants with a serious adverse event related to treatment	Day 1, Day 4±1, day 90±7
Secondary	Biomarkers	Plasma S100-beta protein	Immediately before RIC/sham at baseline; immediately after RIC/sham on Day 1; day 4±1
Secondary	Biomarkers	Plasma heat-shock proteins	Immediately before RIC/sham at baseline; immediately after RIC/sham on Day 1; day 4±1
Secondary	Biomarkers	Plasma cytokines	Immediately before RIC/sham at baseline; immediately after RIC/sham on Day 1; day 4±1
Secondary	Impairment	National Institutes of Health Stroke Scale	Day 4±1, day 90±7
Secondary	Dependency	Modified Rankin scale	Day 90±7
Secondary	Disability	Barthel Index	Day 90±7
Secondary	Mood	Zung depression scale	Day 90±7
Secondary	Telephone cognition	Modified Telephone Interview for Cognitive Status (TICS-M)	Day 90±7