Comprehensive COROnary PHYSiology Assessment in Patients With Angina With Nonobstructive Coronary Arteries - CZECH Republic (CoroPhys-CZECH)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- All-cause death
研究概览
简要总结
Coronary artery disease (CAD) is a leading cause of morbidity and mortality. While cardiologists have been focused on discrete, visible stenoses of coronary arteries, there is increasing awareness of the importance of microcirculation and vasospastic disorders in causing angina. The microvascular bed is composed of vessels smaller than 400 microns in diameter. Their network is significantly larger than that of the epicardial vessels and serves essential functions, including regulating myocardial blood flow and cellular metabolism.
Angina pectoris, a most frequent symptom of CAD or myocardial ischemia, was assumed to be caused by significant stenosis of the epicardial coronary artery. However, it was found that in over 50% of cases, there was no obstructive CAD, which is described as angina with no obstructive coronary arteries (ANOCA) or ischemia with no obstructive coronary arteries (INOCA), according to the clinical setting.
详细描述
Two mechanisms are primarily involved in the pathophysiology: structural and functional impairment, which can affect both epicardial and microcirculatory arteries and may also be combined. Thus, from a clinical point of view, two basic endotypes are distinguished in ANOCA: 1) microvascular angina (MVA) due to structural damage of microcirculation (coronary microvascular dysfunction - CMD), or functional microvascular vasospasm (angina and ECG changes without epicardial vasospasm on acetylcholine testing) and 2) epicardial vasospastic angina (VSA) - angina, ECG changes and vasospasm on acetylcholine testing (Table 1).
- Microvascular Angina (MVA) (FFR > 0,80, iFR > 0,89)
- coronary microvascular dysfunction (CMD) (CFR < 2,0 (2,5), MRR < 2,1, IMR > 25)
- microvascular vasospasm (angina + ECG changes + < 90% epicardial spasm during Ach testing)
- Vasospastic Angina (VSA) (angina + ECG changes + > 90% epicardial spasm during Ach testing)
- Non-coronary chest pain (negative thermodilution and Ach testing)
Table 1 - ANOCA endotypes. FFR - fractional flow reserve, iFR - instantaneous wave-free ratio, CFR - coronary flow reserve, MRR - microvascular resistance reserve, IMR - index of microcirculatory resistance, EKG - electrocardiogram, Ach - acetylcholine.
The clinical manifestation of ANOCA includes a wide range of symptoms that reduce the quality of life and are often misdiagnosed, mistreated, and not infrequently, leading to repeated hospitalizations and invasive investigations. At the same time, patients with both MVA and VSA have a poorer long-term prognosis. Direct assessment of the response of the coronary microcirculation to vasodilator stimuli and diagnosis of vasomotor abnormalities are crucial for accurate stratification and selection of treatment strategies for patients with ANOCA, resulting in reduced angina severity and improved quality of life compared to standard care. Comprehensive invasive coronary functional testing (CFT) is currently the only diagnostic method to establish a definitive diagnosis and characterize a specific ANOCA endotype, supported by professional societies' current recommendations.
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults of both sexes older than 18 years
- •Angina symptoms or angina equivalent
- •Referred to cath lab for evaluation of CAD
- •Invasive physiology testing performed (microcirculation testing +/- vasospasm testing)
排除标准
- •Persons under the age of 18
- •Pregnant of nursing
- •No coronary physiology measurements were performed
结局指标
主要结局
All-cause death
时间窗: 1 year
All-cause death
Components of MACE
时间窗: 1 year
Cardiovascular death, MI, coronary revascularisation, stroke, hospitalization for heart failure, hospitalization for acute coronary syndrome, repeated coronary angiography
次要结局
未报告次要终点
研究者
Petr Kala, MD
Physician, Principal Investigator
University Hospital, Motol
