跳至主要内容
临床试验/NCT05313919
NCT05313919Unknown不适用

Coronary Microcirculatory Disease and Inflammation in Patients With Chronic Coronary Syndrome and no Significant Coronary Artery Stenosis. MOSAIC-COR Study.

Bartlomiej Guzik1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2020年7月24日最近更新:
适应症

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

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

发起方
Bartlomiej Guzik
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Bartlomiej Guzik

MD, PhD

John Paul II Hospital, Krakow

研究点 (1)

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