Remote Ischaemic Conditioning After Stroke Trial (ReCAST-2) (ReCAST-2)
Primary Purpose
Stroke
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Remote ischaemic conditioning
Sham
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Remote ischaemic conditioning
Eligibility Criteria
Inclusion Criteria:
- Suspected clinical stroke with 6 hours of onset of neurological symptoms;
- Age >18;
- Written or witnessed oral consent, or relative/consultee advice.
Exclusion Criteria:
- 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.
Sites / Locations
- Derby Teaching Hospitals Foundation Trust
- Nottingham University Hospitals NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Remote Ischaemic Conditioning
Control
Arm Description
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: 4 cycles of alternating 5 minutes inflation (up to 30 mmHg) followed by 5 minutes deflation of a standard upper arm blood pressure cuff
Outcomes
Primary Outcome Measures
Trial feasibility
Recruitment feasibility (recruitment rate)
Secondary Outcome Measures
Vascular Event Rate [Safety and Tolerability]
Number of participants with a vascular event (including limb ischaemia, recurrent stroke, myocardial infarction, venous thrombo-embolism)
Treatment Related Serious Adverse Event Rates [Safety and Tolerability]
Number of participants with a serious adverse event related to treatment
Biomarkers
Plasma S100-beta protein
Biomarkers
Plasma heat-shock proteins
Biomarkers
Plasma cytokines
Impairment
National Institutes of Health Stroke Scale
Dependency
Modified Rankin scale
Disability
Barthel Index
Mood
Zung depression scale
Telephone cognition
Modified Telephone Interview for Cognitive Status (TICS-M)
Full Information
NCT ID
NCT02779712
First Posted
January 22, 2016
Last Updated
October 10, 2018
Sponsor
University of Nottingham
1. Study Identification
Unique Protocol Identification Number
NCT02779712
Brief Title
Remote Ischaemic Conditioning After Stroke Trial (ReCAST-2)
Acronym
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
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
August 1, 2016 (Actual)
Primary Completion Date
July 23, 2018 (Actual)
Study Completion Date
July 23, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nottingham
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Remote ischaemic conditioning
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Remote Ischaemic Conditioning
Arm Type
Active Comparator
Arm Description
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
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Remote ischaemic conditioning
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Sham
Intervention Description
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
Primary Outcome Measure Information:
Title
Trial feasibility
Description
Recruitment feasibility (recruitment rate)
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Vascular Event Rate [Safety and Tolerability]
Description
Number of participants with a vascular event (including limb ischaemia, recurrent stroke, myocardial infarction, venous thrombo-embolism)
Time Frame
Day 1, Day 4±1, day 90±7
Title
Treatment Related Serious Adverse Event Rates [Safety and Tolerability]
Description
Number of participants with a serious adverse event related to treatment
Time Frame
Day 1, Day 4±1, day 90±7
Title
Biomarkers
Description
Plasma S100-beta protein
Time Frame
Immediately before RIC/sham at baseline; immediately after RIC/sham on Day 1; day 4±1
Title
Biomarkers
Description
Plasma heat-shock proteins
Time Frame
Immediately before RIC/sham at baseline; immediately after RIC/sham on Day 1; day 4±1
Title
Biomarkers
Description
Plasma cytokines
Time Frame
Immediately before RIC/sham at baseline; immediately after RIC/sham on Day 1; day 4±1
Title
Impairment
Description
National Institutes of Health Stroke Scale
Time Frame
Day 4±1, day 90±7
Title
Dependency
Description
Modified Rankin scale
Time Frame
Day 90±7
Title
Disability
Description
Barthel Index
Time Frame
Day 90±7
Title
Mood
Description
Zung depression scale
Time Frame
Day 90±7
Title
Telephone cognition
Description
Modified Telephone Interview for Cognitive Status (TICS-M)
Time Frame
Day 90±7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Suspected clinical stroke with 6 hours of onset of neurological symptoms;
Age >18;
Written or witnessed oral consent, or relative/consultee advice.
Exclusion Criteria:
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.
Facility Information:
Facility Name
Derby Teaching Hospitals Foundation Trust
City
Derby
State/Province
Derbyshire
ZIP/Postal Code
DE22 3DT
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31747864
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.
Results Reference
derived
Learn more about this trial
Remote Ischaemic Conditioning After Stroke Trial (ReCAST-2)
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