Ranolazine Cardioprotection in PCI
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Troponin
研究概览
简要总结
The investigators will test if upfront dosing of Ranolazine can reduce myocardial biomarker release (CK-MB, Troponin) post percutaneous coronary intervention (PCI).
详细描述
Ranolazine has been demonstrated to decrease angina, ischemia on perfusion imaging, improve diastolic function, and cardiac metabolism. Furthermore it has been associated with reduced cardiac arrhythmias, including non-sustained ventricular tachycardia and atrial fibrillation. It has not been studied as an acute cardioprotective agent in percutaneous coronary intervention (PCI).
We hypothesize that upfront administration of Ranolazine could decrease the myocardial injury associated with PCI due to all the factors listed above (i.e. precondition the myocardium). We plan to screen all patients scheduled for an elective coronary angiogram. Those who meet criteria and consent will be randomized to either receive Ranolazine or placebo twice a day for 3 days leading up to the PCI.
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
- 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
- •Age 18 or older
- •Patients undergoing Coronary Angiography with possible PCI
- •Able and willing to give consent
- •Able to read and write English
排除标准
- •Current EKG or Biomarker of Acute Myocardial Infarction (MI) or Acute Coronary Syndromes (ACS)
- •History of Allergy to Ranolazine
- •Pregnant or Nursing
- •Currently taking Ranolazine
研究组 & 干预措施
Ranolazine
Oral treatment Intervention: Drug: Ranolazine 1000 mg
干预措施: Ranolazine (Drug)
Placebo
Oral treatment Intervention: Drug: Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Troponin
时间窗: 8-10 hrs post PCI
Troponin labs will be drawn 8-10 hrs after PCI or at discharge whichever comes first
CK-MB
时间窗: 8-10 hrs post PCI
CK-MB labs will be drawn 8-10 hrs after PCI or at discharge whichever comes first
次要结局
- TIMI Flow Rate (Grade)(TIMI Flow Rate (Grade) is assessed immediately after an interventional reperfusion attempt during a PCI (Percutaneous Coronary Intervention) procedure.)
- Incidence of Non-sustained Ventricular Tachycardia or Atrial Fibrillation Post PCI(Following completion of PCI through hospital discharge)
- Death, Myocardial Infarction (Biomarker Greater Than 2x Normal), CHF, Cardiac Arrest(At discharge or within 1 days, whichever comes first)
- Left Ventricular End Diastolic Pressure (LVEDP)(During the PCI (Percutaneous Coronary Intervention) procedure - starting at timepoint of guidewire insertion into the access artery until removal of guidewire)
- Incidence of Atrial Fibrillation, Ventricular Tachycardia, or Ventricular Fibrillation in Coronary Cath Lab(During the PCI (Percutaneous Coronary Intervention) procedure - starting at timepoint of guidewire insertion into the access artery until removal of guidewire)
- Death, MI, Revascularization, CHF(1-4 weeks post PCI)
- Successful PCI(At discharge or within 1 days, whichever comes first)
研究者
Harvey Hahn
Director, Cardiovascular Fellowship Training Program and Director, Cardiac Noninvasive Laboratory
Kettering Health Network