Safety and Effectiveness of Remote Ischemic Conditioning With the autoRIC Prior to Elective Percutaneous Coronary Intervention (PCI) Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 30
- 主要终点
- (Primary Effectiveness) Attenuation of myocardial injury assessed by Cardiac Troponin I levels (cTnI)
研究概览
简要总结
The purpose of the study is to evaluate the hypothesis that patients receiving remote ischemic conditioning using the autoRIC device show statistically significant reduction in the prevalence of ischemia-reperfusion injury to the myocardium as compared to patients in the autoRIC Sham device arm (within 12-24 hours post non-emergent PCI with stent implantation).
详细描述
This is a multi-center, randomized, controlled single-blind clinical trial to evaluate the safety and effectiveness of the autoRIC device to attenuate myocardial injury as measured by cardiac Troponin I (cTnI) levels in patients undergoing PCI with stent implantation.
Eligible patients that are scheduled for an elective PCI, or unscheduled/non-emergent PCI, or patients scheduled for a diagnostic catheterization procedure with orders of "treat as indicated" will be enrolled in the study. Patients will undergo remote ischemic conditioning with the autoRIC device or the control procedure with the autoRIC Sham device completed ≤ 1 hour prior to balloon or stent inflation. Subjects will have measurements of cTnI levels at baseline and 4-8 and 12-24 hours post completion of the PCI procedure. Adverse events will be recorded through study exit for all patients. Patients will be exited from the study after completion of their 30-day post-procedure telephone follow-up.
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
- Single (Participant)
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
- •Subject is ≥ 18 years of age
- •Subject is scheduled for elective PCI, or unscheduled but non-emergent PCI, or diagnostic catheterization with PCI if indicated. For non-elective cases, there must be at least two troponin levels within the upper limit of normal (ULN), at least 6 hours apart prior to the index procedure
- •Subject is willing and capable of providing written informed consent
- •If the subject is a woman of childbearing potential, she must have had a negative pregnancy test within 24 hours of the study procedure
排除标准
- •Subject requires emergency PCI (i.e., PCI for evolving or ongoing STEMI/NSTEMI)
- •Subject has an elevated troponin level (cTnI or T) > ULN at baseline, based on lab results obtained from the treating institution
- •Subject is scheduled to undergo PCI with the use of Propofol
- •Subject has a recent history of drug treatment with potassium channel activators (e.g., Nicorandil) or potassium channel blockers (e.g., sulfonylureas) during the last 7 days prior to baseline
- •Subject had STEMI during the last 4 weeks prior to baseline. (Note: NSTEMI in the last 4 weeks prior to baseline is allowed if the baseline troponin is ≤ ULN.)
- •Underwent a CABG in the last 4 weeks prior to baseline
- •Had a PCI within the last 7 days prior to baseline
- •Subject has a life expectancy < 6 months
- •Subject has NYHA Class IV or decompensated heart failure
- •Subject has peripheral vascular disease requiring intervention during the index hospitalization or within 4 weeks post-procedure
- •Subject has either serum creatinine >2 times the age-appropriate upper limit of normal, a glomerular filtration rate (GFR) of < 30 mL/min/1.73m2 or requires dialysis
- •Subject has systolic blood pressure > 200 mmHg
- •Subject is currently being treated with systemic oral or I.V. steroids
- •Subject has a known bleeding disorder or known abnormality of blood flow to the limb to be treated
- •Subject has peripheral nerve injury, abnormal nerve supply, peripheral neuropathy or pre-existing traumatic injury to the limb to be treated
- •Subject is scheduled for a PCI procedure to treat a known Chronic Total Occlusion (CTO) lesion
- •Subject is currently participating in or is planning to participate in another investigational drug or device trial, prior to the 30-day follow-up visit. (Note: Observational studies or post-approval studies/ registries, are allowed.)
- •Planned (staged) post-index procedure intervention within 30 days (i.e., PCI of non-target lesions in any vessel or CABG). (Note: Planned revascularization (PCI or bypass) of a non-target lesion >30 days following the index procedure is allowed.)
- •Any cardiac surgical procedure planned within 30 days post-enrollment
研究组 & 干预措施
autoRIC
The autoRIC device will be used on subjects randomized to the treatment group.
干预措施: autoRIC (Device)
autoRIC Sham
The autoRIC Sham device will be used on subjects randomized to the control group.
干预措施: autoRIC Sham (Device)
结局指标
主要结局
(Primary Effectiveness) Attenuation of myocardial injury assessed by Cardiac Troponin I levels (cTnI)
时间窗: 12-24 hours
The proportion of subjects with cTnI levels above the 99th percentile Upper Reference Limit (URL) (0.04 ng/mL) 12-24 hours post-PCI.
(Primary Safety) Major Adverse Cardiac Events (MACE)
时间窗: 30 days
The proportion of subjects with major adverse cardiac events (MACE) within 30 days. MACE is defined as: death, stroke, myocardial infarction or the need for target vessel revascularization.
次要结局
- Type 4a Myocardial Infarction (MI)(12-24 hours)
- Contrast-Induced Acute Kidney Injury (CI-AKI)(12-24 hours)