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Remote Ischaemic Conditioning in Endovascular Recanalization for Proximal Anterior Circulation Occlusion Study

NCT03152799 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-05-15

No results posted yet for this study

Summary

Ischaemic stroke causes significant morbidity and mortality and is a leading cause of disability within an ageing United Kingdom (UK) population. Proximal anterior circulation occlusion is associated with a particularly poor prognosis, but its management has undergone a paradigm shift following clinical introduction of endovascular recanalization, establishing rapid reperfusion of the ischaemic penumbra.

Remote ischaemic conditioning (RIC) is highly effective at attenuating cerebral infarction in basic research studies and has the potential to further improve patient outcome if used as an adjunct to invasive revascularisation strategies. We aim to trial remote ischaemic conditioning at the time of revascularisation, and then daily for the duration of the seven-day in-patient stay, compared to a sham conditioning procedure. This pilot, single-centre study will determine efficacy/ tolerability of RIC to reduce cerebral infarction (primary endpoint: determined by brain magnetic resonance imaging \[MRI\]) and improve functional status (secondary end-points: National Institutes of Health Stroke Severity (NIHSS); European Quality of Life questionnaire EurQoL), with the data providing the necessary parameters for power calculations and leveraging charitable funding for a subsequent multi-centre study.

Conditions

Interventions

PROCEDURE

RIPC Remote Ischaemic Pre-Conditioning

intermittent limb ischaemia via a peripheral blood pressure cuff inflation and deflation

OTHER

Sham Control

intermittent peripheral blood pressure cuff inflation and deflation which does not induce a protective cellular response

Sponsors & Collaborators

  • University College London Hospitals

    collaborator OTHER

  • National Hospital for Neurology and Neurosurgery (NHNN) at Queen Square

    collaborator UNKNOWN

  • University College, London

    lead OTHER

Principal Investigators

  • Robert M Bell, PhD MRCP · Hatter Cardiovascular Institute UCL

  • Derek Yellon, PhD DSc · Hatter Cardiovascular Institute UCL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2019-08-01
Completion
2019-12-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03152799 on ClinicalTrials.gov