Ischemia With No Obstruction of Coronary Arteries: Underlying Mechanisms and the Impact of Exercise Training (EXINOCA)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Change in Myocardial Blood Flow Reserve (MBFR)
研究概览
简要总结
The purpose of the study is to identify causes of chest pain in patients experiencing chest pain with no signs of narrowing of the coronary arteries of the heart, and to investigate whether physical exercise can improve coronary microvascular function.
Hypotheses:
The first hypothesis is that in INOCA, with reduced function of microvasculature of the heart, this reduced function also occurs in other organs of the body.
The second hypothesis is that regular physical activity (aerobic exercise training) can improve coronary microvascular function, reduce symptoms, and that there is a parallel improvement in vascular function in other organs of the body.
详细描述
A significant number of patients suspected of chronic coronary syndrome do not have coronary artery obstruction and in a large proportion of these, their symptoms are attributed to coronary microvascular dysfunction (CMD), a condition known as ischemia with no obstructive coronary artery disease (INOCA). Despite a considerable patient population affected by INOCA, the specific mechanisms underlying CMD are not fully understood, often resulting in a lack of targeted treatment. There is evidence to suggest that exercise capacity is linked to coronary microvascular function, positing that exercise training could potentially reverse microvascular dysfunction and address its mechanistic origins, a hypothesis yet to be explored.
This study aims to identify mechanisms underlying CMD in angina and to assess whether exercise training can improve the condition.
The current study is a randomized controlled trial testing the effect of exercise training in patients with CMD. 100 patients will be randomized 1:1 to exercise training or control. The primary outcome is coronary microvascular function, secondary outcomes include symptoms and microvascular function in cutaneous tissue, skeletal muscle, and adipose tissue.
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
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Coronary microvascular dysfunction, defined as myocardial bloodflow reserve (MBFR) < 2.5 or hyperemic myocar-dial blood flow (hMBF)<2.3 ml/g/min using [15O]H2O-PET
- •No obstructive coronary artery disease
排除标准
- •Females of childbearing potential (defined as a premeno-pausal female capable of becoming pregnant). The female patient must either be postmenopausal, defined as amen-orrhea for at least 1 year, or surgically sterile
- •Heart failure, defined as left ventricular ejection fraction of less than 40%
- •Uncontrolled hypertension defined as blood pressure above target 140/90 for all
- •Co-morbidity resulting in <1 year expected survival
- •Considered by the investigator, for any reason, to be an un-suitable candidate for the study.
- •Unable or unwilling to exercise, e.g. due to arthritis or in-jury*
- •Already are regularly physically active and/or have a maxi-mal oxygen uptake >45 ml/kg/min
结局指标
主要结局
Change in Myocardial Blood Flow Reserve (MBFR)
时间窗: From baseline and after 3 months
Change in MBFR assessed by \[15O\]H2O-PET-scan
次要结局
- Change in symptom burden assessed by Seattle Angina Questionnaire(From baseline and after 3 months)
- Change in exercise capacity(From baseline and after 3 months)
- Change in global rest perfusion in patients with angina symptoms and CMD(From baseline and after 3 months)
- Change in global stress perfusion in patients with angina symptoms and CMD(From baseline and after 3 months)
研究者
Eva Prescott
MD Clinical Professor
Bispebjerg Hospital