Coronary Microcirculatory Disease and Inflammation in Patients With Chronic Coronary Syndrome and no Significant Coronary Artery Stenosis. MOSAIC-COR Study.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Diastolic Disfunction parameters in ECHO
研究概览
简要总结
Patients with chronic coronary syndromes (CCS) diagnosed without significant lesions in invasive coronary angiography (ischemia non-obstructive coronary artery disease - INOCA) represent approximately 50% of all patients with CCS. Results of FAME study clearly showed that evaluation of coronary circulation should not be accomplished only with visual assessment in resting conditions. Current European Society of Cardiology Guidelines of diagnosis and treatment of CCS published in 2019 emphasize the necessity of performing complex coronary physiology assessment. Invasive physiological measurements and vasoreactivity provocative tests emerged as key tools to differentiate between vasospastic angina, microcirculatory angina, overlap of both conditions or non-cardiac disease. According to contemporary literature, identification of heterogeneity of patients with INOCA is crucial for determination of adequate treatment. An appropriate pharmacotherapy has a potential to improve outcomes including grade of angina, quality of life, exertional tolerance and most important - MACCE (major adverse cardiac and cardiovascular events) free survival. However, there is a lack of evidence on each of the subtypes of INOCA especially in those with signs and symptoms of vasospasm in provocative test but without visual spasm in epicardial vessels.
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 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed chronic coronary syndrome CCS ≥
- •Evidence of myocardial ischemia (positive result of non-invasive stress test).
- •Informed consent.
- •Age at least 18 years.
排除标准
- 未提供
结局指标
主要结局
Diastolic Disfunction parameters in ECHO
时间窗: baseline, 12- and 24-month follow-up
Cytokines (serum levels)
时间窗: baseline
次要结局
- FMD(baseline, 12- and 24-month observation)
- MACCE occurrence(baseline, 12- and 24-month observation)
- symptoms intensity and quality of life (questionnaires)(baseline, 12- and 24-month observation)
- Hospitalization any(baseline, 12- and 24-month observation)
研究者
Bartlomiej Guzik
MD, PhD
John Paul II Hospital, Krakow
