Protective Effects of Remote Ischemic Conditioning in Elderly With Acute Ischemic Stroke Complicating Acute Coronary Syndrome: A Single-center Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Major adverse cardiac and cerebrovascular events (MACCEs)
研究概览
简要总结
Remote ischemic conditioning (RIC) is a noninvasive strategy in which one or more cycles of brief and transient limb ischemia confers protection against prolonged and severe ischemia in distant organs.This study aimed to investigate whether RIC is safe and effective in patients with AIS complicating ACS
详细描述
Remote ischemic conditioning (RIC) is a noninvasive strategy in which one or more cycles of brief and transient limb ischemia confers protection against prolonged and severe ischemia in distant organs (e.g., brain and heart).It has been demonstrated to be an effective strategy to reduce plasma myocardial enzyme, infarct volume, and incidence of post-ACS heart failure in patients with ACS. Additionally, recent studies have found that RIC was safe and feasible in patients with AIS even in those caused by large artery occlusion and treated with reperfusion therapy, and it might benefit AIS patients by reducing the risk of brain tissue infarction and improving functional outcomes. To date, however, it is still unknow whether RIC, a systematic protective strategy, could benefit patients with AIS complicating ACS.This study aimed to investigate whether RIC is safe and effective in patients with AIS complicating ACS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The RIC and sham procedure were performed by using identical devices with different cuff pressures (200mmHg versus 60 mmHg). Patients, investigators, and raters were all blinded to the treatment assignment.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AIS within 24 hours after symptom onset which meet the diagnostic criteria for acute ischemic stroke of the 2013th ASA guidelines, AIS was defined as a clinical episode of neurological dysfunction caused by focal cerebral infarction that can be detected on imaging(e.g.,computed tomography or magnetic resonance imaging of head)
- •ACS within 24 hours of stroke onset , and ACS contains ST-segment elevation myocardial infarction, non-ST-elevation myocardial infarction, unstable angina and it was defined when there is a rise and/or fall of plasma cardiac biomarkers (e.g., myocardial enzyme，cardiac troponin I), along with supportive evidence in the form of typical symptoms (e.g., chest pain), suggestive electrocardiographic changes, or imaging evidence of new loss of viable myocardium or new regional wall motion abnormality
- •The patients missed the opportunity of or contradicted to reperfusion therapy (i.e., intravenous thrombolysis and endovascular treatments) for both AIS and ACS.
- •Informed consent obtained
排除标准
- •Unstable vital signs
- •Prior ipsilateral stroke with residual deficits
- •AIS caused by cardioembolism, suspicious arterial dissection, intracranial sinus thrombolysis, vasculitis, and moyamoya disease.
- •Intracranial bleeding.
- •Advanced malignancy.
- •Uncontrolled hypertension (defined as systolic blood pressure ≥200 mm Hg despite medications at enrollment).
- •Any vascular, soft tissue, or orthopedic injury (eg, superficial wounds and fractures of the arm) that contraindicated bilateral arm ischemic preconditioning.
- •Peripheral vascular disease that affecting the upper limbs' arteries
- •Any disorder that could potentially increase pre-stroke myocardial enzyme concentrations (eg, percutaneous coronary intervention or myocardial infarction within the previous 6 weeks)
- •Coronary artery stenosis requiring coronary bypass surgery for the index event within 3 months; or severe heart failure requiring mechanical ventilation or use of an intra-aortic balloon pump
- •Taking drugs in the study period or are participating in other clinical trials.
- •Severe psychiatric disease.
- •Patients who cannot keep treatment or follow-up.
结局指标
主要结局
Major adverse cardiac and cerebrovascular events (MACCEs)
时间窗: from baseline to 3 months after therapy
MACCEs defined as all cause of death and recurrence of cardiac and cerebrovascular ischemic events within 3 months after randomization
次要结局
- the proportion of patients achieving functional independence(from baseline to 3 months after therapy)
- the national institutes of health stroke (NIHSS) score(changes from baseline to 7 days, 14 days ,30 days, 90 days after therapy)
- plasma hypersensitive C-reactive protein（hs-CRP） level(changes from baseline to 2 weeks after therapy)
- global registry of acute coronary events (GRACE) score(changes from baseline to 7 days, 14 days ,30 days, 90 days after therapy)
- modified Rankin scale（mRs）(changes from baseline to 7 days, 14 days ,30 days, 90 days after therapy)
研究者
Ji Xunming,MD,PhD
professor
Capital Medical University