A Single Center Diagnostic Study of Endothelial Inflammation and Health Status in Patients With Ischemia and Nonobstructive Coronary Arteries (INOCA)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Change in Seattle Angina Questionnaire (SAQ) score
研究概览
简要总结
The purpose of this study is to evaluate coronary artery and peripheral vein vascular endothelial profiles in patients with ischemia with non-obstructive coronary arteries (INOCA) who undergo coronary function testing (CFT). The aims are: (1) Evaluate coronary artery endothelial profiles and associations with coronary microvascular dysfunction (CMD) in INOCA. (2) Assess brachial vein endothelial cell profiles in patients with INOCA and associations with CMD, and (3) Characterize relationships between endothelial signatures and anginal symptoms, functional status, and physical activity at baseline and 1-year follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Adult age ≥18 years referred for clinically indicated coronary angiography
- •Chronic coronary disease or potentially ischemic symptoms as the indication for coronary angiography
- •Possible or suspected ischemia with non-obstructive epicardial coronary arteries (INOCA)
排除标准
- •Clinical (Pre-Cath) Exclusion criteria:
- •Anemia (hemoglobin <9 mg/dl)
- •Severe valvular heart disease
- •Acute myocardial infarction within 30 days
- •Severe valvular heart disease
- •New York Heart Association (NYHA) Functional Class III or IV heart failure
- •Hypertrophic obstructive cardiomyopathy or severe left ventricular hypertrophy
- •Pregnancy (because of potential exercise/activity limitations and symptom changes)
研究组 & 干预措施
Non-Obstructive CAD
Participants with ischemia with non-obstructive coronary arteries (INOCA) and endothelial sampling will be fully eligible for long-term follow up. A Wearable activity monitoring device (Fitbit) will be provided post-procedure to these participants. Participants will be followed for a minimum of 1 year.
干预措施: Invasive coronary angiography (Procedure)
Non-Obstructive CAD
Participants with ischemia with non-obstructive coronary arteries (INOCA) and endothelial sampling will be fully eligible for long-term follow up. A Wearable activity monitoring device (Fitbit) will be provided post-procedure to these participants. Participants will be followed for a minimum of 1 year.
干预措施: Coronary Artery Endothelial Cell Sampling (Procedure)
Non-Obstructive CAD
Participants with ischemia with non-obstructive coronary arteries (INOCA) and endothelial sampling will be fully eligible for long-term follow up. A Wearable activity monitoring device (Fitbit) will be provided post-procedure to these participants. Participants will be followed for a minimum of 1 year.
干预措施: Fitbit (Device)
Non-Obstructive CAD
Participants with ischemia with non-obstructive coronary arteries (INOCA) and endothelial sampling will be fully eligible for long-term follow up. A Wearable activity monitoring device (Fitbit) will be provided post-procedure to these participants. Participants will be followed for a minimum of 1 year.
干预措施: Invasive coronary function testing (Diagnostic Test)
Obstructive CAD
Participants with obstructive coronary artery disease (CAD) at the time of angiography may undergo endothelial sampling and blood collection but will not be provided a wearable activity monitoring device or undergo long-term follow up.
干预措施: Invasive coronary angiography (Procedure)
Obstructive CAD
Participants with obstructive coronary artery disease (CAD) at the time of angiography may undergo endothelial sampling and blood collection but will not be provided a wearable activity monitoring device or undergo long-term follow up.
干预措施: Coronary Artery Endothelial Cell Sampling (Procedure)
结局指标
主要结局
Change in Seattle Angina Questionnaire (SAQ) score
时间窗: Baseline, 1 year follow up
The Seattle Angina Questionnaire (SAQ) scores range from 0 to 100 for all five domains (Physical Limitations, Angina Stability, Angina Frequency, Treatment Satisfaction, and Quality of Life), with higher scores indicating better health status, fewer limitations, and less frequent angina. A 10-point change in score is typically considered clinically significant.
Change in Duke Activity Status Index (DASI) score
时间窗: Baseline, 1 year follow up
The DASI is a 12-item self-report questionnaire used to assess a patient's functional capacity. Scores range from 0 to 58.2, with higher scores indicating better functional capacity.
次要结局
未报告次要终点