Randomized-controlled Trial of a Combined vs. Conventional Percutaneous Intervention for Near-Infrared Spectroscopy Defined High-Risk Native Coronary Artery Lesions
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 主要终点
- Reduction of the incidence and size of periprocedural MI, as assessed by the peak post-PCI troponin distribution
研究概览
简要总结
Design: Single center, single-blind randomized controlled trial of patients with high risk native coronary artery lesions (defined as ≥2 contiguous yellow blocks on the block chemogram) requiring clinically indicated percutaneous coronary intervention. Patients will be randomized to either a combined intervention or conventional PCI. Cardiac biomarker measurements will be performed before PCI and 18-24 hours later.
Treatment: Combined intervention consisting of pre-PCI intracoronary vasodilator and glycoprotein IIb/IIIa inhibitor administration, use of an EPD if technically feasible, and complete coverage of the lipid core plaque, if technically feasible.
Control: Conventional PCI. Duration: 30 days follow-up. The primary trial objective is to compare the incidence and size of periprocedural MI, as assessed by the peak post-PCI troponin distribution in the two study groups.
The secondary endpoints are: (1) Reduction in the incidence of >3x and >10x upper limit of normal increase in CK-MB. (2) Reduction in the incidence of slow flow/no-reflow post PCI. (3) Lower incidence of major adverse cardiac events, defined as the composite of death, acute coronary syndrome, or coronary revascularization) during 30-day 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
- Treatment
- 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
- •Age ≥18 years.
- •Willing and able to provide informed consent and able to comply with study procedures and follow-up.
- •Undergoing a clinically indicated left heart coronary catheterization
- •Need PCI of a high-risk native coronary artery lesion. High-risk lesions will be defined as lesions with ≥2 contiguous yellow blocks on block chemogram.
排除标准
- •Coexisting conditions that limit life expectancy to less than 30-days or that could affect the patient's compliance with the protocol.
- •Positive pregnancy test or breast-feeding.
- •High risk for bleeding.
- •Subject is currently, or within the 30 preceding days, participating in a device or pharmaceutical treatment protocol.
- •Clinical presentation with ST-segment elevation MI.
- •Persistent (>10 minutes) hypotension (systolic blood pressure <90 mmHg)
- •Need for revascularization of multiple lesions during the index PCI.
- •Unprotected left main (>50%) or equivalent left main disease.
研究组 & 干预措施
Combined Intervention
Combined intervention: pre-PCI intracoronary vasodilator and glycoprotein IIb/IIIa inhibitor administration, use of an EPD if technically feasible, and complete coverage of the lipid core plaque, if technically feasible
干预措施: Combined Intervention (Procedure)
Conventional PCI
Conventional PCI
干预措施: Conventional PCI (Procedure)
结局指标
主要结局
Reduction of the incidence and size of periprocedural MI, as assessed by the peak post-PCI troponin distribution
时间窗: 18-24 hours post-procedure
次要结局
- Reduction in the incidence of >3x and >10x upper limit of normal increase in CK-MB(18-24 hours post-procedure)
- Reduction in the incidence of slow flow/no-reflow post PCI(2-3 hours after)
- Lower incidence of major adverse cardiac events, defined as the composite of death, acute coronary syndrome, or coronary revascularization) during 30-day follow-up(30 days)
研究者
Emmanouil Brilakis
Director of Cardiac Catheterization Laboratories, Professor of Medicine
North Texas Veterans Healthcare System