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Remote Ischaemic Conditioning After Stroke Trial (ReCAST-2) (ReCAST-2)

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ClinicalTrials.gov Identifier: NCT02779712
Recruitment Status : Completed
First Posted : May 20, 2016
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Stroke Procedure: Remote ischaemic conditioning Procedure: Sham Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : August 1, 2016
Actual Primary Completion Date : July 23, 2018
Actual Study Completion Date : July 23, 2018

Arm Intervention/treatment
Active Comparator: 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
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 Comparator: Control
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
Procedure: 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




Primary Outcome Measures :
  1. Trial feasibility [ Time Frame: 90 days ]
    Recruitment feasibility (recruitment rate)


Secondary Outcome Measures :
  1. Vascular Event Rate [Safety and Tolerability] [ Time Frame: 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)

  2. Treatment Related Serious Adverse Event Rates [Safety and Tolerability] [ Time Frame: Day 1, Day 4±1, day 90±7 ]
    Number of participants with a serious adverse event related to treatment

  3. Biomarkers [ Time Frame: Immediately before RIC/sham at baseline; immediately after RIC/sham on Day 1; day 4±1 ]
    Plasma S100-beta protein

  4. Biomarkers [ Time Frame: Immediately before RIC/sham at baseline; immediately after RIC/sham on Day 1; day 4±1 ]
    Plasma heat-shock proteins

  5. Biomarkers [ Time Frame: Immediately before RIC/sham at baseline; immediately after RIC/sham on Day 1; day 4±1 ]
    Plasma cytokines

  6. Impairment [ Time Frame: Day 4±1, day 90±7 ]
    National Institutes of Health Stroke Scale

  7. Dependency [ Time Frame: Day 90±7 ]
    Modified Rankin scale

  8. Disability [ Time Frame: Day 90±7 ]
    Barthel Index

  9. Mood [ Time Frame: Day 90±7 ]
    Zung depression scale

  10. Telephone cognition [ Time Frame: Day 90±7 ]
    Modified Telephone Interview for Cognitive Status (TICS-M)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02779712


Locations
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United Kingdom
Derby Teaching Hospitals Foundation Trust
Derby, Derbyshire, United Kingdom, DE22 3DT
Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
Sponsors and Collaborators
University of Nottingham

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Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT02779712     History of Changes
Other Study ID Numbers: 16007
First Posted: May 20, 2016    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University of Nottingham:
Remote ischaemic conditioning
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases