Ischemic Stroke Clinical Trial
— RICE PACOfficial title:
Remote Ischaemic Conditioning in Endovascular Recanalization for Proximal Anterior Circulation Occlusion (RICE PAC) Study
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.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | December 31, 2019 |
Est. primary completion date | August 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University College, London | National Hospital for Neurology and Neurosurgery (NHNN) at Queen Square, University College London Hospitals |
Bell RM, Yellon DM. There is more to life than revascularization: therapeutic targeting of myocardial ischemia/reperfusion injury. Cardiovasc Ther. 2011 Dec;29(6):e67-79. doi: 10.1111/j.1755-5922.2010.00190.x. Epub 2010 Jul 14. Review. — View Citation
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. — View Citation
Department of Health: Progress in Improving Stroke Care. In: Office NA, editor.: The Stationary Office; 2010.
Hahn CD, Manlhiot C, Schmidt MR, Nielsen TT, Redington AN. Remote ischemic per-conditioning: a novel therapy for acute stroke? Stroke. 2011 Oct;42(10):2960-2. doi: 10.1161/STROKEAHA.111.622340. Epub 2011 Aug 11. — View Citation
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.
Hougaard KD, Hjort N, Zeidler D, Sørensen L, Nørgaard A, Hansen TM, von Weitzel-Mudersbach P, Simonsen CZ, Damgaard D, Gottrup H, Svendsen K, Rasmussen PV, Ribe LR, Mikkelsen IK, Nagenthiraja K, Cho TH, Redington AN, Bøtker HE, Østergaard L, Mouridsen K, Andersen G. Remote ischemic perconditioning as an adjunct therapy to thrombolysis in patients with acute ischemic stroke: a randomized trial. Stroke. 2014 Jan;45(1):159-67. doi: 10.1161/STROKEAHA.113.001346. Epub 2013 Nov 7. — View Citation
Meng R, Asmaro K, Meng L, Liu Y, Ma C, Xi C, Li G, Ren C, Luo Y, Ling F, Jia J, Hua Y, Wang X, Ding Y, Lo EH, Ji X. Upper limb ischemic preconditioning prevents recurrent stroke in intracranial arterial stenosis. Neurology. 2012 Oct 30;79(18):1853-61. doi: 10.1212/WNL.0b013e318271f76a. Epub 2012 Oct 3. — View Citation
Moore JM, Griessenauer CJ, Gupta R, Adeeb N, Patel AS, Ogilvy CS, Thomas AJ. Landmark papers in cerebrovascular neurosurgery 2015. Clin Neurol Neurosurg. 2016 Sep;148:22-8. doi: 10.1016/j.clineuro.2016.06.007. Epub 2016 Jun 18. Review. — View Citation
Ren C, Wang P, Wang B, Li N, Li W, Zhang C, Jin K, Ji X. Limb remote ischemic per-conditioning in combination with post-conditioning reduces brain damage and promotes neuroglobin expression in the rat brain after ischemic stroke. Restor Neurol Neurosci. 2015;33(3):369-79. doi: 10.3233/RNN-140413. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | reduction of infarct size as proportion of ischaemic penumbra following revascularisation | Proportion of ischaemic penumbra determined by MRI at 3 months post-revascularisation | 3 months after revascularisation / thrombectomy | |
Secondary | Reduction of cerebral oedema and infarct size (second-phase reperfusion injury) | Proportion of ischaemic penumbra comparing MRI data at 24 hours and 7 days post-thrombectomy | MRI at 7 days post-thrombectomy | |
Secondary | Neurological Recovery at 24 h and 3 months post-revascularisation | modified Rankin Score | at 24h hours and 3 months post-revascularisation | |
Secondary | Neurological Recovery at 24 h and 3 months post-revascularisation | NIHSS (National Institutes of Health Stroke Scale) | at 24h hours and 3 months post-revascularisation | |
Secondary | Neurological Recovery at 24 h and 3 months post-revascularisation | QoL (Quality of Life) assessment | at 24h hours and 3 months post-revascularisation |
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