Clinical Relevance of Coronary Microvascular Dysfunction Assessments in Myocardial Infarction With Non-Obstructive Coronary Arteries
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- MACCE
研究概览
简要总结
To compare clinical outcomes of myocardial infarction with non-obstructive coronary arteries (MINOCA) according to the coronary microvascular dysfunction (CMD), evaluated by optical coherence tomography (OCT), invasive and non-invasive coronary physiologic assessment.
详细描述
Background Approximately 5~10% of patients with acute myocardial infarction (AMI) have been reported as myocardial infarction with non-obstructive coronary arteries (MINOCA) in the contemporary clinical setting. Although those with MINOCA have a better prognosis than with obstructive coronary artery disease, several observational studies continuously reported that patients with MINOCA showed comparable outcomes. One plausible explanation of this discrepancy is the heterogeneous and variable definition of MINOCA. Possible causes of MINOCA include plaque erosion and/or rupture, vasospasm, and CMD. Therefore, it is natural that heterogeneous pathophysiology of MINOCA causes diagnostic challenges and proper management.
Recently, there have been efforts for establishing the diagnosis of MINOCA and standardizing the systematic management according to the cause of MINOCA. According to the AHA scientific statement, patients who suspected MINOCA have been recommended to perform multimodality approach, including intravascular imaging (i.e., OCT). Although non-invasive methods, such as N-13 ammonia positron emission tomography (PET), can be used for evaluating the CMD, invasive coronary physiologic assessment using pressure-temperature wire has been recommended. CMD has been known as a major cause of MINOCA, and it may be required specific treatment.
Nevertheless, there has no data on the outcomes of MINOCA with or without CMD. Therefore, the aim of CMD-MINOCA sought to assess the MINOCA patients regarding the latest clinical pathway for diagnosis of CMD and evaluate their clinical outcomes at 2 years.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject with age ≥19 years and acute myocardial infarction
- •Rise and/or fall of cardiac troponin with one level >99 percentile plus ischemic signs/symptoms
- •Subject with non-obstructive coronary arteries
- •<50% diameter stenosis or
- •fractional flow reserve (FFR) >0.80 ③ Subject without previous history of coronary artery disease
- •Subject who performed invasive coronary angiography within 24 hours after presentation ⑤ Subject who eligible for invasive and non-invasive coronary physiologic assessment
排除标准
- •Subject with obstructive coronary arteries
- •Subject with alternate diagnosis including sepsis, pulmonary embolism, myocarditis, Takotsubo syndrome, spontaneous coronary dissection, and other cardiomyopathies.
- •Subject with cardiogenic shock or cardiac arrest ④ Subject who has non-cardiac co-morbid conditions with life expectancy <1 year ⑤ Subject or lactating women ⑥ Subject unable to provide consent
研究组 & 干预措施
MINOCA with CMD
MINOCA patients with CMD proven by invasive or non-invasive method
干预措施: Intravascular imaging (OCT), Invasive physiologic assessment (FFR, CFR, IMR), or Non-invasive physiologic assessment (N-13 ammonia PET) (Diagnostic Test)
MINOCA without CMD
MINOCA patients without CMD
干预措施: Intravascular imaging (OCT), Invasive physiologic assessment (FFR, CFR, IMR), or Non-invasive physiologic assessment (N-13 ammonia PET) (Diagnostic Test)
结局指标
主要结局
MACCE
时间窗: 2-Year after enrollment
a composite of cardiac death, any MI, any revascularization, stroke, readmission due to heart failure
次要结局
- cardiac death(2-Year after enrollment)
- re-admission due to heart failure(2-Year after enrollment)
- all-cause death, any MI, or any revascularization(2-Year after enrollment)
- Changes of left ventricular ejection fraction(2-Year after enrollment)
- Rate of myocardial infarction(2-Year after enrollment)
- Changes of Coronary flow reserve(6-Month after enrollment)
- Rate of stroke(2-Year after enrollment)
- Rate of repeat revascularization(2-Year after enrollment)
- all-cause death(2-Year after enrollment)
研究者
Young Joon Hong
Professor
Chonnam National University Hospital