Remote Ischaemic Conditioning in Endovascular Recanalization for Proximal Anterior Circulation Occlusion Study (RICE PAC)
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ClinicalTrials.gov Identifier: NCT03152799 |
Recruitment Status : Unknown
Verified May 2017 by University College, London.
Recruitment status was: Not yet recruiting
First Posted : May 15, 2017
Last Update Posted : May 15, 2017
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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.
Condition or disease | Intervention/treatment | Phase |
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Ischemic Stroke | Procedure: RIPC Remote Ischaemic Pre-Conditioning Other: Sham Control | Phase 1 |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | pilot, single-centre, double-blind, sham-controlled (non-clinical trial of investigational medicinal product [non-CTIMP]) study of repeated daily remote ischaemic conditioning vs placebo/sham in the context of acute anterior circulation stroke |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | Participants, Care Provider / Clinician Health Professional, Investigator, and Outcomes assessors will be blinded to the allocation and randomisation of study participatants. It is anticipated that |
Primary Purpose: | Treatment |
Official Title: | Remote Ischaemic Conditioning in Endovascular Recanalization for Proximal Anterior Circulation Occlusion (RICE PAC) Study |
Estimated Study Start Date : | August 1, 2017 |
Estimated Primary Completion Date : | August 1, 2019 |
Estimated Study Completion Date : | December 31, 2019 |

Arm | Intervention/treatment |
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Experimental: Remote Ischaemic Pre-Conditioning (RIPC) Intervention
Remote Ischaemic Pre-Conditioning intervention to be applied via peripheral blood pressure cuff inflation/deflations to upper lower limb contra-lateral to affected side of hemiparesis
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Procedure: RIPC Remote Ischaemic Pre-Conditioning
intermittent limb ischaemia via a peripheral blood pressure cuff inflation and deflation
Other Name: Remote Ischaemic PreConditioning |
Sham Comparator: Sham Control
Sham Control to be applied via peripheral blood pressure cuff inflation/deflations to upper lower limb contra-lateral to affected side of hemiparesis
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Other: Sham Control
intermittent peripheral blood pressure cuff inflation and deflation which does not induce a protective cellular response |
- reduction of infarct size as proportion of ischaemic penumbra following revascularisation [ Time Frame: 3 months after revascularisation / thrombectomy ]Proportion of ischaemic penumbra determined by MRI at 3 months post-revascularisation
- Reduction of cerebral oedema and infarct size (second-phase reperfusion injury) [ Time Frame: MRI at 7 days post-thrombectomy ]Proportion of ischaemic penumbra comparing MRI data at 24 hours and 7 days post-thrombectomy
- Neurological Recovery at 24 h and 3 months post-revascularisation [ Time Frame: at 24h hours and 3 months post-revascularisation ]modified Rankin Score
- Neurological Recovery at 24 h and 3 months post-revascularisation [ Time Frame: at 24h hours and 3 months post-revascularisation ]NIHSS (National Institutes of Health Stroke Scale)
- Neurological Recovery at 24 h and 3 months post-revascularisation [ Time Frame: at 24h hours and 3 months post-revascularisation ]QoL (Quality of Life) assessment

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Acute, symptomatic proximal anterior circulation occlusion
- able to commence remote ischaemic conditioning within 6h of symptom onset
- identified as candidate for endovascular intervention according to local criteria
Exclusion Criteria:
- Age < 18 years
- Coagulopathy; International Normalised Ratio (INR) >2, alteplase dose > 90mg or 0.9mg/kg; platelet count < 50 x 10^9/L
- pregnancy
- BP >= 185/110 despite therapeutic intervention
- medical illness which interferes with outcome assessments (disability from other neurological disease)
- dependent on others for activities of daily living (ADLs) prior to current stroke (mRS modified Rankin Score was 3 - 5).
- unlikely to be able to participate in study follow-up procedures (lives > 100 miles away; no fixed abode)
- already enrolled in another clinical trial involving investigational medicinal product or device
- baseline scan demonstrating significant prior infarction in the affected Middle Cerebral Artery (MCA) territory or an infarct that exceeds > 1/3 MCA territory

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): NCT03152799
Contact: Richard Perry, PhD MRCP | 020 3448 3416 | richard.perry@uclh.nhs.uk | |
Contact: Robert Simister, PhD MRCP | 020 3448 3416 | robert.simister@uclh.nhs.uk |
Principal Investigator: | Robert M Bell, PhD MRCP | Hatter Cardiovascular Institute UCL | |
Study Director: | Derek Yellon, PhD DSc | Hatter Cardiovascular Institute UCL |
Publications:
Responsible Party: | University College, London |
ClinicalTrials.gov Identifier: | NCT03152799 |
Other Study ID Numbers: |
222254 |
First Posted: | May 15, 2017 Key Record Dates |
Last Update Posted: | May 15, 2017 |
Last Verified: | May 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
remote ischaemic conditioning remote ischemic conditioning cerebral infarction ischaemia reperfusion injury |
ischemia reperfusion injury anterior circulation stroke mechanical thrombectomy |
Ischemic Stroke Ischemia Stroke Cerebrovascular Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Pathologic Processes |