Impact of Ranalozine on Coronary Microcirculatory Resistance- A Prospective Single Center Study to Evaluate the Effect of Ranalozine in Microcirculatory Resistance (MICRO Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Number of Participants Assessed for Relative Change in the Index of Microcirculatory Resistance Before and After Ranolazine Therapy
研究概览
简要总结
This study is being done to determine if Ranolazine treatment improves coronary microcirculation function among patients with coronary microcirculation dysfunction. We are also looking to learn if symptomatic improvement of chest pain during treatment with Ranalozine is related to improved coronary microcirculation function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •- Patients with subjective symptoms of ischemia without flow limiting angiographic CAD (<50% epicardial coronary stenosis) and abnormal IMR (>20 U).
- •Definition of ischemia (any one):
- •chest pain with dynamic ischemic ECG changes (t wave inversions or > 1 mm ST depressions
- •Exercise treadmill testing induced chest pain with ≥1 mm of downsloping or flat ST segment depression during exercise or recovery; ≥2 mm of ischemic ST depression at a low workload (stage 2 or less or ≤130 beats/min); early onset (stage 1) or prolonged duration (>5 min) of ST depression; multiple leads (>5) with ST depression
- •Nuclear stress perfusion defect > 10%
- •Stress echocardiogram with stress induced wall motion abnormality
排除标准
- •- Age < 18 yrs
- •Flow Limiting epicardial CAD >50%
- •Life expectancy < 6 months
- •Recent (<1 week) myocardial infarction or positive biomarkers
- •Severe aortic stenosis
- •Contraindications to IMR testing including inability to utilize antithrombotic therapy and/or intravenous adenosine
- •Contraindications to Ranolazine therapy:
- •Patients with known hepatic insufficiency, prolonged QT or renal failure (GFR < 60)
- •use of drugs that inhibit CYP3A such as diltiazem, verapamil, ketoconazole, macrolides and HIV protease inhibitors
- •Pregnancy, breastfeeding
- •Patients taking drugs which prolong QT interval
研究组 & 干预措施
Ranalozine
After enrollment in the study, participants will initiate Ranolazine for 4 weeks. The participant's usual anti-anginal medication regimen will be continued unchanged throughout study duration. Patients will receive Ranolazine 500 mg orally twice daily for 1 week, and the dose will be increased to 1,000 mg twice daily for an additional 3 weeks if tolerated.
干预措施: Rnalozine (Drug)
结局指标
主要结局
Number of Participants Assessed for Relative Change in the Index of Microcirculatory Resistance Before and After Ranolazine Therapy
时间窗: 4 weeks
次要结局
未报告次要终点