Stepwise Treatment and Acetylcholine Rechallenge in Vasospastic Angina to Guide Patient-tailored Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- The percent of ACH provoked spasm that is no longer inducible by ACH after IC injection of verapamil.
研究概览
简要总结
The goal of this clinical trial is to assess the feasibility and clinical value of acetylcholine (ACH) rechallenge after intracoronary verapamil +- nitroglycerine in a patient cohort with angina and non-obstructive coronary arteries (ANOCA).
The main questions it aims to answer are:
- to determine the efficacy of these drugs in treating ACH-induced coronary artery spasm
- to determine the efficacy of these drugs in preventing ACH-induced coronary artery spasm
The ACH rechallenge will take place during the index coronary function tests in patients with proven ACH-induced vasospastic angina. The study is considered a feasibility study, no control arm is included.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Clinically indicated coronary angiogram in the setting of angina with non-obstructive coronary artery disease (ANOCA)
- •Non-obstructive coronary artery disease is defined as the absence of coronary artery stenosis ≥ 50%, or if ≥ 50% with non-ischemic resting (RFR > 0.89) and hyperemic indices (FFR > 0.80).
- •ACH provoked epicardial and/or microvascular spasm
- •Left ventricular ejection fraction (LVEF) > 50%
- •Renal function with eGFR ≥ 40 ml/min
排除标准
- •Obstructive coronary artery disease (both chronic and acute coronary coronary syndromes)
- •Any cardiomyopathy (including takotsubo stress cardiomyopathy) or severe valvular disease
- •LVEF < 50%
- •Long QT syndrome (LQTS) - genetic or acquired
- •Ventricular paced rhythm
- •Renal failure with eGFR < 40 ml/min
- •Thyroid stimulating hormone (TSH) < lower limit of normal (LLN). A subject taking thyroid replacement therapy may be enrolled with TSH level below LLN if, in the opinion of the investigator, the subject is in a clinically euthyroid state.
- •Known hypersensitivity or contra-indication for either acetylcholine, verapamil, nicorandil or nitroglycerine.
- •Pregnant female subjects. Female subjects of child-bearing potential should be on adequate contraceptive measures or are to be screened with a urine pregnancy test.
结局指标
主要结局
The percent of ACH provoked spasm that is no longer inducible by ACH after IC injection of verapamil.
时间窗: Baseline
Is verapamil able to suppress ACH-induced coronary artery spasm?
The percent of ACH provoked spasm that is no longer inducible by ACH after sequential IC injection of verapamil and NTG.
时间窗: Baseline
Is verapamil + NTG able to suppress ACH-induced coronary artery spasm?
次要结局
- The percent of ACH provoked spasm that resolves after IC administration of verapamil.(Baseline)
- The percent of ACH provoked spasm that resolves after sequential IC administration of verapamil and NTG.(Baseline)