NCT02779712: ReCAST-2

Remote Ischaemic Conditioning After Stroke Trial (ReCAST-2)

Completed Phase 2 Last updated 11 October 2018

What this trial tests

Phase 2 trial testing Remote ischaemic conditioning in Stroke in 60 participants. Completed in 23 July 2018.

Timeline

1 August 2016

Primary endpoint
23 July 2018

23 July 2018

Quick facts

Lead sponsor	University of Nottingham
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	60
Start date	1 August 2016
Primary completion	23 July 2018
Estimated completion	23 July 2018
Sites	2 locations across United Kingdom

Drugs / interventions tested

• Remote ischaemic conditioning
• Sham

Conditions studied

• Stroke — all drugs for Stroke →

Sponsor

University of Nottingham

Who can join

18 and older, any sex, with Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Remote ischemic conditioning for stroke: clinical data, challenges, and future directions.
   Zhao W, Li S, Ren C, Meng R, et al · · 2019 · cited 45× · PMID 30656197 · DOI 10.1002/acn3.691
2. Remote Ischemic Conditioning After Stroke Trial 2: A Phase IIb Randomized Controlled Trial in Hyperacute Stroke.
   England TJ, Hedstrom A, O'Sullivan SE, Woodhouse L, et al · · 2019 · cited 44× · PMID 31747864 · DOI 10.1161/jaha.119.013572
3. Remote ischaemic conditioning for preventing and treating ischaemic stroke.
   Zhao W, Zhang J, Sadowsky MG, Meng R, et al · · 2018 · cited 36× · PMID 29974450 · DOI 10.1002/14651858.cd012503.pub2
4. Induced neuroprotection by remote ischemic perconditioning as a new paradigm in ischemic stroke at the acute phase, a systematic review.
   Purroy F, García C, Mauri G, Pereira C, et al · · 2020 · cited 19× · PMID 32615939 · DOI 10.1186/s12883-020-01836-8
5. Peripheral Mechanisms of Remote Ischemic Conditioning.
   Yang J, Shakil F, Cho S. · · 2019 · cited 18× · PMID 32313875
6. Efficacy and safety of remote ischemic conditioning for acute ischemic stroke: A comprehensive meta-analysis from randomized controlled trials.
   Kan X, Yan Z, Wang F, Tao X, et al · · 2023 · cited 17× · PMID 37183341 · DOI 10.1111/cns.14240
7. The effect of repeated remote ischemic postconditioning on infarct size in patients with an ischemic stroke (REPOST): study protocol for a randomized clinical trial.
   Landman T, Schoon Y, Warlé M, De Leeuw FE, et al · · 2019 · cited 15× · PMID 30876432 · DOI 10.1186/s13063-019-3264-0
8. Ischemic stroke and intervention strategies based on the timeline of stroke progression: Review and prospects.
   Xu A, Zhang H, Zhang Y, Wu J, et al · · 2025 · cited 5× · PMID 41049732 · DOI 10.1016/j.apsb.2025.07.026