NCT05313919

Coronary Microcirculatory Disease and Inflammation in Patients With Chronic Coronary Syndrome and no Significant Coronary Artery Stenosis

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 160 (estimated)
• Sponsor: Bartlomiej Guzik · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: —

Summary

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.

Conditions

• Coronary Artery Disease
• Ischemia and No Obstructive Coronary Arteries
• Ischemic Heart Disease
• Microvascular Angina
• Vasospastic Angina

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Comprehensive functional diagnostics of coronary circulation	Comprehensive functional diagnostics of coronary circulation in patients with INOCA (ischemia and no obstructive coronary arteries) including: * echocardiography with assessment of diastolic function * flow-mediated dilation of brachial artery * coronary angiography * functional coronary assessment (RFR, FFR, IMR, CFR, dp/dt, Tau) * provocative test with acetylcholine (registration of symptoms, ECG and angiographic spasm) * laboratory tests (full blood count, serum creatinine level, eGFR, lipidogram, serum CRP/hsCRP level, serum NT-proBNP level) * serum level of inflammatory cytokines and chemokines

Timeline

• Start date: 2020-07-24
• Primary completion: 2022-12-31
• Completion: 2023-06-30
• First posted: 2022-04-06
• Last updated: 2022-04-06

Locations

1 site across 1 country: Poland