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

Bartlomiej Guzik

Status: Unknown

Conditions: Vasospastic Angina; Ischemic Heart Disease; Coronary Artery Disease; Microvascular Angina; Ischemia and No Obstructive Coronary Arteries

Treatments: Diagnostic Test: Comprehensive functional diagnostics of coronary circulation

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05313919

304/KBL/OIL2019

PL-2020-01 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Diagnosed chronic coronary syndrome CCS ≥ 2.
2. Evidence of myocardial ischemia (positive result of non-invasive stress test).
3. Informed consent.
4. Age at least 18 years.

Exclusion Criteria:

Trial design

160 participants in 4 patient groups

1. Coronary microcirculatory disease

Treatment:

Diagnostic Test: Comprehensive functional diagnostics of coronary circulation

2. Epicardial vasospastic angina

Treatment:

Diagnostic Test: Comprehensive functional diagnostics of coronary circulation

3. Microvessel vasospastic angina

Treatment:

Diagnostic Test: Comprehensive functional diagnostics of coronary circulation

4. Non-cardiac disorder

Treatment:

Diagnostic Test: Comprehensive functional diagnostics of coronary circulation