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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
Sponsor:
Collaborators:
University College London Hospitals
National Hospital for Neurology and Neurosurgery (NHNN) at Queen Square
Information provided by (Responsible Party):
University College, London

Brief 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.


Condition or disease Intervention/treatment Phase
Ischemic Stroke Procedure: RIPC Remote Ischaemic Pre-Conditioning Other: Sham Control Phase 1

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Neurological Recovery at 24 h and 3 months post-revascularisation [ Time Frame: at 24h hours and 3 months post-revascularisation ]
    modified Rankin Score

  3. 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)

  4. 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



Information from the National Library of Medicine

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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:

  • 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

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): NCT03152799


Contacts
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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

Sponsors and Collaborators
University College, London
University College London Hospitals
National Hospital for Neurology and Neurosurgery (NHNN) at Queen Square
Investigators
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Principal Investigator: Robert M Bell, PhD MRCP Hatter Cardiovascular Institute UCL
Study Director: Derek Yellon, PhD DSc Hatter Cardiovascular Institute UCL
Additional Information:
Publications:
Department of Health: Progress in Improving Stroke Care. In: Office NA, editor.: The Stationary Office; 2010.
Hippisley-Cox J, Pringle M, Ryan R. Stroke: Prevalence, Incidence and Care in General Practices 2002-2004. Final Report to the National Stroke Audit Team. In: Physicians RCo, editor. 2004.
Berkhemer OA, Fransen PS, Beumer D, van den Berg LA, Lingsma HF, Yoo AJ, Schonewille WJ, Vos JA, Nederkoorn PJ, Wermer MJ, van Walderveen MA, Staals J, Hofmeijer J, van Oostayen JA, Lycklama à Nijeholt GJ, Boiten J, Brouwer PA, Emmer BJ, de Bruijn SF, van Dijk LC, Kappelle LJ, Lo RH, van Dijk EJ, de Vries J, de Kort PL, van Rooij WJ, van den Berg JS, van Hasselt BA, Aerden LA, Dallinga RJ, Visser MC, Bot JC, Vroomen PC, Eshghi O, Schreuder TH, Heijboer RJ, Keizer K, Tielbeek AV, den Hertog HM, Gerrits DG, van den Berg-Vos RM, Karas GB, Steyerberg EW, Flach HZ, Marquering HA, Sprengers ME, Jenniskens SF, Beenen LF, van den Berg R, Koudstaal PJ, van Zwam WH, Roos YB, van der Lugt A, van Oostenbrugge RJ, Majoie CB, Dippel DW; MR CLEAN Investigators. A randomized trial of intraarterial treatment for acute ischemic stroke. N Engl J Med. 2015 Jan 1;372(1):11-20. doi: 10.1056/NEJMoa1411587. Epub 2014 Dec 17. Erratum in: N Engl J Med. 2015 Jan 22;372(4):394.

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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University College, London:
remote ischaemic conditioning
remote ischemic conditioning
cerebral infarction
ischaemia reperfusion injury
ischemia reperfusion injury
anterior circulation stroke
mechanical thrombectomy
Additional relevant MeSH terms:
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Ischemic Stroke
Ischemia
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes