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

Coronary Artery Disease Clinical Trial

— MOSAIC-COR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05313919
• Other study ID #: 304/KBL/OIL2019
• Secondary ID: PL-2020-01
• Status: Recruiting
• Start date: July 24, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: March 2022
• Source: John Paul II Hospital, Krakow
• Contact: Bartlomiej Guzik, MD, PhD
• Phone: +48 614 35 01
• Email: b.guzik[@]uj.edu.pl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: June 30, 2023
• Est. primary completion date: December 31, 2022
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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:

Related Conditions & MeSH terms

• Angina Pectoris
• Angina Pectoris, Variant
• Coronary Artery Disease
• Coronary Disease
• Coronary Stenosis
• Heart Diseases
• Inflammation
• Ischemia
• Ischemic Heart Disease
• Microvascular Angina
• Myocardial Ischemia
• Vasospastic Angina

Intervention

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

Locations

Country	Name	City	State
Poland	Department of Interventional Cardiology, John Paul II Hospital, Krakow, Poland, Institute Of Cardiology, Jagiellonian University Medical College	Krakow	Lesser Poland

Sponsors (2)

Lead Sponsor	Collaborator
Bartlomiej Guzik	Abbott

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cytokines (serum levels)		baseline
Primary	Diastolic Disfunction parameters in ECHO		baseline, 12- and 24-month follow-up
Secondary	MACCE occurrence		baseline, 12- and 24-month observation
Secondary	Hospitalization any		baseline, 12- and 24-month observation
Secondary	symptoms intensity and quality of life (questionnaires)		baseline, 12- and 24-month observation
Secondary	FMD		baseline, 12- and 24-month observation