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NCT Number: NCT02779712

Remote Ischaemic Conditioning After Stroke Trial (ReCAST-2)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Derby Teaching Hospitals Foundation Trust, Derby, Derbyshire, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Remote ischaemic conditioning

Procedure

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

Procedure

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 outcomes

  1. Trial feasibility

    Time frame: 90 days

    Recruitment feasibility (recruitment rate)

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Registry information

Official study 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

Acronym: ReCAST-2

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 20, 2016
Registry last updated
Oct 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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