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

• Conditions: Coronary Artery Disease; Ischemic Heart Disease; Vasospastic Angina; Ischemia and No Obstructive Coronary Arteries; Microvascular Angina
• Interventions: Diagnostic Test: Comprehensive functional diagnostics of coronary circulation

• Registration Number: NCT05313919
• Lead Sponsor: Bartlomiej Guzik

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-24
• Status Verified: 2022-03
• Study First Submitted: 2022-03-29
• Study First Submitted QC: 2022-03-29
• Last Update Submitted: 2022-03-29
• Study First Posted: 2022-04-06
• Last Update Posted: 2022-04-06
• Primary Completion: 2022-12-31
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
4. Non-cardiac disorder	Comprehensive functional diagnostics of coronary circulation	-
3. Microvessel vasospastic angina	Comprehensive functional diagnostics of coronary circulation	-
1. Coronary microcirculatory disease	Comprehensive functional diagnostics of coronary circulation	-
2. Epicardial vasospastic angina	Comprehensive functional diagnostics of coronary circulation	-

Primary Outcome Measures

Name	Time	Method
Diastolic Disfunction parameters in ECHO	baseline, 12- and 24-month follow-up
Cytokines (serum levels)	baseline

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Interventional Cardiology, John Paul II Hospital, Krakow, Poland, Institute Of Cardiology, Jagiellonian University Medical College; 🇵🇱 Krakow, Lesser Poland, Poland