Effect of Trimetazidine on the Improvement of Coronary Microvascular Dysfunction in Patients With INOCA(Ischemia and no Obstructive Coronary Artery Disease)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 主要终点
- Coronary flow reserve (CFR) improves
研究概览
简要总结
This is a prospective study which aims to explore the effect of Trimetazidine on the improvement of coronary microvascular dysfunction in patients with INOCA (ischemia and no obstructive coronary artery disease). Enrolled patients will be assessed SAQ(Seattle Angina Score), Canadian Angina Grade(Canadian Cardiovascular Society, CCS), Six-Minute Walk Test, CFR(coronary flow reserve) .CFR inspection with D-SPECT and pressure guide wire.Patients will receive six months Trimetazidine(35mg tid) after enrollment. And their SAQ (Seattle Angina Score), Canadian Angina Grade(Canadian Cardiovascular Society, CCS), Six-Minute Walk Test, CFR will be followed up.
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
- •age≥18 years
- •Typical angina symptoms
- •Coronary angiography or coronary computed tomography examination showed no significant epicardial coronary artery stenosis (<20%)
- •Never used trimetazidine
- •The CFR measured by the pressure guide wire is less than 2.0
- •agree to participant the study and sign informed written consent
- •available for six months follow up
排除标准
- •Severe liver and kidney disease
- •Contraindications of Trimetazidine
- •Use of CYP3A inhibitors, such as diltiazem, verapamil, and other drugs that may affect CFR measurements
- •QT interval extension
- •Atrial fibrillation or left bundle branch block
- •Left ventricular systolic dysfunction (EF <55%)
- •Coronary artery fistula
- •Myocardial bridge
- •Non-cardiogenic chest pain and other heart diseases
- •Severe heart valve disease
- •Recent ACS( Acute coronary syndrome)
- •Pregnancy
- •Failed to complete inspection
研究组 & 干预措施
Trimetazidine
干预措施: Trimetazidine (Drug)
结局指标
主要结局
Coronary flow reserve (CFR) improves
时间窗: six months
次要结局
- Seattle angina score or Canadian angina grade drops(six months)
- Six-minute walking experiment improves(six months)
研究者
Ya-Wei Xu
The chief director of department of cardiology
Shanghai 10th People's Hospital