Remote Ischaemic Conditioning in Endovascular Recanalization for Proximal Anterior Circulation Occlusion (RICE PAC) Study
试验速览
- 阶段
- 1 期
- 入组人数
- 60
- 主要终点
- reduction of infarct size as proportion of ischaemic penumbra following revascularisation
研究概览
简要总结
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.
详细描述
The aims of our study are to:
- Demonstrate safety of remote ischaemic conditioning (RIC) in stroke patients;
- Demonstrate practicality of the intervention (RIC);
- Demonstrate the practicality of the study protocol and imaging modalities;
- Determining appropriate and measurable end-points: e.g. cerebral infarct reduction (MRI), reduction of cerebral oedema, functional assessment and quality of life survey;
- Provide preliminary data on likely effect size of the RIC intervention versus the sham procedure.
Background and Rationale:
Acute ischaemic stroke represents a significant cause of morbidity and mortality in the UK. It is estimated that 110,000 strokes occur in England each year, with an incidence of between 1-36/1000/year. Patients presenting with a proximal vessel occlusion in the anterior circulation have a particularly poor prognosis, with approximately 20% 90-day mortality and significant morbidity despite thrombolysis. Recently, endovascular recanalization with mechanical thrombectomy trials have brought about a paradigm shift in the optimal management of this high-risk group of patients; the interventional extraction of the occluding thrombus demonstrating significant benefits in MR-CLEAN(3), ESCAPE, EXTEND-IA (intra-arterial), SWIFT PRIME and REVASCAT (revascularisation) studies. Echoing primary percutaneous intervention in the management of ST-elevation myocardial infarction, endovascular recanalization represents rapid restoration of blood flow to the ischaemic cerebrum - with the promise of improved neurological salvage and functional outcome.
Reperfusion Injury:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
reduction of infarct size as proportion of ischaemic penumbra following revascularisation
时间窗: 3 months after revascularisation / thrombectomy
Proportion of ischaemic penumbra determined by MRI at 3 months post-revascularisation
次要结局
- Reduction of cerebral oedema and infarct size (second-phase reperfusion injury)(MRI at 7 days post-thrombectomy)
- Neurological Recovery at 24 h and 3 months post-revascularisation(at 24h hours and 3 months post-revascularisation)