A Randomized Controlled Study of Targeted Medical Therapy Versus Placebo for Angina and Non- Obstructive Coronary Arteries: The MVP-ANOCA Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Seattle Angina Questionnaire summary score
研究概览
简要总结
The goal of this clinical trial is to learn if targeted medical therapy will improve symptoms and quality of life in patients with angina and non-obstructive coronary arteries compared to placebo, after the underlying cause of the chest pain has been ascertained by coronary function testing.
Participants will be treated with either medications that target the underlying cause of their chest pain or placebo for 4 weeks after a drug titration phase of 1-3 weeks. They will be asked to complete a series of questionnaires to evaluate their quality of life at the beginning and end of the study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •All patients with stable angina referred to the Stanford University Hospital cardiac catheterization laboratory for clinically indicated coronary function testing are eligible for inclusion into the study.
- •Specific inclusion criteria for randomization:
- •Absence of significant epicardial coronary artery disease on angiography
- •Fractional flow reserve > 0.80
- •And ≥ 1 of the following:
- •Epicardial coronary spasm on acetylcholine testing
- •Microvascular spasm on acetylcholine testing
- •Coronary flow reserve < 2.5
- •Index of microcirculatory resistance ≥ 25
- •Myocardial bridge on intravascular ultrasound with dobutamine resting full-cycle ratio ≤ 0.76
排除标准
- •Acute coronary syndrome less than one week prior to enrolment
- •Cardiomyopathy
- •Contraindications to beta-blockers or calcium channel blockers
- •Baseline systolic blood pressure < 95 mmHg
- •Baseline heart rate < 55 bpm
研究组 & 干预措施
Placebo
- Epicardial or microvascular coronary spasm: Placebo
- Coronary microvascular dysfunction: Placebo
- Myocardial Bridge: Placebo
- Mixed epicardial/microvascular spasm and coronary microvascular dysfunction/myocardial bridge: Placebo
Participants will take their assigned therapy after randomization. Weekly person via in-person visit or telephone is performed to uptitrate therapy to the maximally tolerated dose. After 1-3 weeks, the initial drug titration phase is completed and a final dose reached. Participants are then instructed to take the maximally tolerated dose for an additional 4 weeks to the conclusion of the study.
干预措施: Placebo (Drug)
Targeted medical therapy
- Epicardial or microvascular coronary spasm: Amlodipine 2.5mg initial dose, 10mg max dose
- Coronary microvascular dysfunction: Nebivolol 5mg initial dose, 20mg max dose
- Myocardial Bridge: Nebivolol 5mg initial dose, 20mg max dose
- Mixed epicardial/microvascular spasm and coronary microvascular dysfunction/myocardial bridge: Amlodipine 2.5mg initial dose, 10mg max dose; PLUS Nebivolol 5mg initial dose, 20mg max dose
Participants will take their assigned therapy after randomization. Weekly person via in-person visit or telephone is performed to uptitrate therapy to the maximally tolerated dose. After 1-3 weeks, the initial drug titration phase is completed and a final dose reached. Participants are then instructed to take the maximally tolerated dose for an additional 4 weeks to the conclusion of the study.
干预措施: Amlodipine (Drug)
Targeted medical therapy
- Epicardial or microvascular coronary spasm: Amlodipine 2.5mg initial dose, 10mg max dose
- Coronary microvascular dysfunction: Nebivolol 5mg initial dose, 20mg max dose
- Myocardial Bridge: Nebivolol 5mg initial dose, 20mg max dose
- Mixed epicardial/microvascular spasm and coronary microvascular dysfunction/myocardial bridge: Amlodipine 2.5mg initial dose, 10mg max dose; PLUS Nebivolol 5mg initial dose, 20mg max dose
Participants will take their assigned therapy after randomization. Weekly person via in-person visit or telephone is performed to uptitrate therapy to the maximally tolerated dose. After 1-3 weeks, the initial drug titration phase is completed and a final dose reached. Participants are then instructed to take the maximally tolerated dose for an additional 4 weeks to the conclusion of the study.
干预措施: Nebivolol (Drug)
结局指标
主要结局
Seattle Angina Questionnaire summary score
时间窗: 5-7 weeks (depending on drug titration period)
Change in Seattle Angina Questionnaire summary score at follow-up compared to baseline. The score ranges from 0 - 100, with a higher score indicating a better outcome.
次要结局
- EuroQol 5 dimension - 5L index score(5-7 weeks (depending on drug titration period))
- EuroQol 5 dimension - 5L visual analogue score(5-7 weeks (depending on drug titration period))
- PHQ-4 score(5-7 weeks (depending on drug titration period))
- Treatment Satisfaction Questionnaire for Medication score(5-7 weeks (depending on drug titration period))
- Seattle Angina Questionnaire summary score stratified by specific chest pain endotypes(5-7 weeks (depending on drug titration period))
- EuroQol 5 dimension - 5L index score stratified by specific chest pain endotypes(5-7 weeks (depending on drug titration period))
- EuroQol 5 dimensions - 5L visual analogue score stratified by specific chest pain endotypes(5-7 weeks (depending on drug titration period))
- PHQ-4 scores stratified by specific chest pain endotypes(5-7 weeks (depending on drug titration period))
- Treatment Satisfaction Questionnaire for Medication score stratified by specific chest pain endotypes(5-7 weeks (depending on drug titration period))
- Seattle Angina Questionnaire summary score stratified by baseline angina frequency(5-7 weeks (depending on drug titration period))
- Proportion of patients with good response, no angina, and excellent health status(5-7 weeks (depending on drug titration period))
- Safety endpoints(Baseline)
- Major adverse cardiac events(5-7 weeks (depending on drug titration period))
研究者
Christopher Chi-Yuen Wong
Postdoc
Stanford University