A Single Center Study of Perivascular Coronary Inflammation in Patients With Myocardial Ischemia or Infarction With Non-Obstructive Coronary Arteries
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Perivascular coronary fat attenuation will be significantly greater in MINOCA patients compared with INOCA patients
研究概览
简要总结
Among patients with ischemic heart disease who are referred for coronary angiography, a substantial proportion have non-obstructive coronary artery disease (CAD). Myocardial infarction (MI) with non-obstructive coronary artery disease (MINOCA) accounts for 5-20% of patients with MI and preferentially affects women. MINOCA pathogenesis is varied and may include atherosclerotic plaque rupture, plaque erosion with thrombosis, vasospasm, embolization, dissection or a combination of mechanisms. Other patients may have clinically unrecognized myocarditis, or takotsubo syndrome masquerading as MI. Among patients referred for coronary angiography for the evaluation of stable ischemic heart disease, non-obstructive CAD is present in up to ~30% of men and ~60% of women. Stable ischemia with non-obstructive coronary arteries (INOCA) may be due to coronary microvascular dysfunction in up to 40% of these patients. Our understanding of mechanisms of MINOCA and INOCA remain incomplete. Coronary inflammation has been hypothesized as a potential mechanism contributing to coronary spasm in MINOCA and microvascular disease in INOCA.
详细描述
The PericOronary INflammaTion in Non-Obstructive Coronary Artery Disease (POINT-NOCAD) study is a single-center diagnostic, observational study enrolling men and women with MINOCA or INOCA who are planned to undergo (or underwent) clinically indicated coronary angiography. The research plan is to evaluate coronary inflammation, as measured by the perivascular coronary fat attenuation index from non-invasive coronary computed tomography angiography (CCTA), in patients with MINOCA and INOCA.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 125 Years（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
- •Stable ischemic heart disease OR acute myocardial infarction as the indication for coronary angiography
排除标准
- •Clinical Exclusion criteria:
- •Estimated glomerular filtration rate < 45 mL/min
- •History of allergic reaction to iodinated contrast media
- •Pregnancy
- •Angiographic / Post-Cath Exclusion criteria:
- •Obstructive CAD (≥50% luminal obstruction in ≥1 major epicardial coronary arteries by invasive coronary angiography)
- •Allergic reaction to iodinated contrast media
研究组 & 干预措施
Intervention group
Participants will be identified by review of the cardiac catheterization laboratory schedule each day by the principal investigator, a co-investigator, or a research coordinator. Participants with no obstructive CAD and completed microvascular testing will undergo a research CCTA.
干预措施: Coronary computed tomography angiography (CCTA) (Procedure)
Intervention group
Participants will be identified by review of the cardiac catheterization laboratory schedule each day by the principal investigator, a co-investigator, or a research coordinator. Participants with no obstructive CAD and completed microvascular testing will undergo a research CCTA.
干预措施: Isovue (Drug)
Intervention group
Participants will be identified by review of the cardiac catheterization laboratory schedule each day by the principal investigator, a co-investigator, or a research coordinator. Participants with no obstructive CAD and completed microvascular testing will undergo a research CCTA.
干预措施: Nitroglycerin (Drug)
Intervention group
Participants will be identified by review of the cardiac catheterization laboratory schedule each day by the principal investigator, a co-investigator, or a research coordinator. Participants with no obstructive CAD and completed microvascular testing will undergo a research CCTA.
干预措施: Metoprolol (Drug)
结局指标
主要结局
Perivascular coronary fat attenuation will be significantly greater in MINOCA patients compared with INOCA patients
时间窗: Visit 1, Day 0
Images obtained from the CCTA will be used to calculate perivascular FAI, measured around the proximal left anterior descending artery and in the right coronary artery, in the proximal 10 to 50 mm of the vessel. For each coronary vessel, will define the weighted mean attenuation of all adipose tissue-containing voxels (-190 to -30 Hounsfield units \[HU\]) located within a radial distance from the outer vessel wall equal to the diameter of the respective vessel.
Perivascular coronary fat attenuation will be greater in INOCA patients with versus without coronary microvascular disease
时间窗: Visit 1, Day 0
Images obtained from the CCTA will be used to calculate perivascular FAI, measured around the proximal left anterior descending artery and in the right coronary artery, in the proximal 10 to 50 mm of the vessel. For each coronary vessel, will define the weighted mean attenuation of all adipose tissue-containing voxels (-190 to -30 Hounsfield units \[HU\]) located within a radial distance from the outer vessel wall equal to the diameter of the respective vessel.
Perivascular coronary fat attenuation in patients with MINOCA will be greatest in the culprit coronary vessels with evidence of acute plaque disruption.
时间窗: Visit 1, Day 0
Images obtained from the CCTA will be used to calculate perivascular FAI, measured around the proximal left anterior descending artery and in the right coronary artery, in the proximal 10 to 50 mm of the vessel. For each coronary vessel, will define the weighted mean attenuation of all adipose tissue-containing voxels (-190 to -30 Hounsfield units \[HU\]) located within a radial distance from the outer vessel wall equal to the diameter of the respective vessel.
次要结局
未报告次要终点