Identification of Mechanisms Behind Microvascular Dysfunction in Ischemia With No Obstructive Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Vascular function in response to acetylcholine stress
研究概览
简要总结
The purpose of the study is to identify the causes of chest pain in patients experiencing chest pain with no signs of narrowing in the coronary arteries of the heart.
详细描述
A significant number of patients with ischemic heart disease do not exhibit coronary obstruction, leading to their symptoms being attributed to coronary microvascular dysfunction, a condition known as ischemia with no obstructive coronary artery disease (INOCA). Despite a considerable patient population affected by INOCA, the specific mechanisms underlying this microvascular dysfunction 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, an area yet to be explored.
This study aims to identify mechanisms underlying Coronary microvascular dysfunction (CMD) in angina and to assess whether exercise training can improve the condition. In study part I 30 patients with impaired coronary microvascular function and 30 asymptomatic controls will be studied to identify vascular and related molecular mechanisms underlying INOCA by investigating microvascular function in the heart and in cutaneous tissue, skeletal muscle, and adipose tissue.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Only for angina patients: Have CMD, defined as myocardial bloodflow re-serve (MBFR) < 2.5 or hyperemic myocardial blood flow (hMBF) < 2.3ml/g/min
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 unsuitable candidate for the study.
- •Unable or unwilling to exercise, e.g. due to arthritis or injury*
- •Already are regularly physically active and/or have a maximal oxygen uptake >45 ml/kg/min
- •The subject has a known allergy to either: norepinephrine, adenosine, ketorolac, and or ascorbic acid (vitamin C).
结局指标
主要结局
Vascular function in response to acetylcholine stress
时间窗: Baseline only
Vascular conductance measured by ultrasound doppler during infusion of acetylcholine
次要结局
- Vascular function in response to acetylcholine adenosine stress(Baseline only)
- Plasma Levels of Inflammatory Markers(Baseline only)
- Arterial Blood Pressure(Baseline only)
- Myocardial Blood flow reserve(Baseline only)
- Changes in isolated small artery reactivity assessed with myography(Baseline only)
- Plasma Lipids(Baseline only)
- Plasma HbA1c(Baseline only)
- Plasma Levels of Markers Related to Vascular Function(Baseline only)
- Cardiac Function(Baseline only)
- Arterial Compliance(Baseline only)
- Skeletal Muscle Microvascular Function(Baseline only)
研究者
Eva Prescott
MD Clinical Professor
Bispebjerg Hospital