Prevention of Coronary Microvascular Dysfunction Post-PCI by Intracoronary Nicardipine
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in Index of Microcirculatory Resistance (IMR)
研究概览
简要总结
This is a single-center double blind, placebo controlled study of patients undergoing a cardiac catheterization where the need for a percutaneous coronary intervention (PCI) is anticipated or will be determined during the early diagnostic phase. The study will assess the use of intracoronary nicardipine vs. sterile saline injection in reducing the index measurement of microcirculatory resistance (IMR). Fifty consecutive patients presenting to the Thomas Jefferson University (TJUH) Cardiac Catheterization lab will be randomized in a 1:1 fashion to receive either intracoronary nicardipine or sterile saline injection prior to PCI. IMR values will be assessed pre and post procedure. Data on clinical outcomes and adverse events will be collected by phone at 30 days and 1 year following the procedure.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Consenting adults age > 18 years
- •Patients with stable coronary disease, stable angina, and/or objective evidence of myocardial ischemia OR
- •Target vessel lesion with > 50% stenosis treated by PCI
排除标准
- •Patients presenting with ST elevation myocardial infarction
- •Complete total occlusion of the vessel
- •Unprotected left main disease
- •Presentation with acute coronary syndrome and actively rising troponin
- •Contraindication to adenosine (advanced heart blocks, bronchospasm, HSN to the drug)
- •Known hypersensitivity to nicardipine
- •Severe aortic stenosis
- •Left Ventricular dysfunction with ejection fraction less than 30%
- •Hemodynamically unstable defined as systolic blood pressure < 90 mmHg and not responding to IV fluids
- •Significant chronic renal insufficiency (Glomerular filtration rate [GFR] <30)
- •Unwilling or unable to provide informed consent
研究组 & 干预措施
Intracoronary Nicardipine
200 mcg intracoronary injection of nicardipine prior to PCI, with potential for additional 100 mcg nicardipine before stent placement, balloon post-dilation, and before post-PCI IMR measurement.
干预措施: Nicardipine (Drug)
Sterile Saline
Injection of sterile saline prior to PCI, with potential for additional saline injections before stent placement, balloon post-dilation, and before post-PCI IMR measurement.
干预措施: Sterile Saline (Drug)
结局指标
主要结局
Change in Index of Microcirculatory Resistance (IMR)
时间窗: From the start of the PCI procedure to immediately following the PCI procedure
IMR is an intracoronary artery pressure measurement obtained during cardiac catheterization, and is a reliable indicator of microvascular dysfunction
次要结局
- Post-Procedure myocardial Infarction (PMI)(12-18 hours post procedure)
- Major Adverse Cardiac Event(I year following procedure)