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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Ischemic Heart Disease; Microvascular Angina; Vasospastic Angina; Ischemia and No Obstructive Coronary Arteries
• Intervention / Treatment: Diagnostic test: Comprehensive functional diagnostics of coronary circulation

• Study Type: Observational
• Enrollment (Anticipated): 160

Contacts and Locations

• Study Contact: Name: Bartłomiej Guzik, MD, PhD; Phone Number: +48 614 35 01; Email: b.guzik@uj.edu.pl
• Study Contact Backup: Name: Piotr Szolc, MD; Phone Number: +48 614 35 01; Email: piotr.szolc4@gmail.com

Study Locations

• Poland
  • Lesser Poland
    • Krakow, Lesser Poland, Poland, 31-202
      • Recruiting
      • Department of Interventional Cardiology, John Paul II Hospital, Krakow, Poland, Institute Of Cardiology, Jagiellonian University Medical College
      • Contact: Krzysztof Pazdan; Phone Number: +48 12 614 25 85; Email: k.pazdan@szpitaljp2.krakow.pl
      • Sub-Investigator: Paweł Kleczyński, MD, PhD
      • Sub-Investigator: Piotr Szolc, MD
      • Sub-Investigator: Łukasz Niewiara, MD
      • Sub-Investigator: Maciej Stąpór, MD, PhD
      • Sub-Investigator: Anna Bernacik, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with symptomatic chronic coronary syndrome and no significant lesions in epicardial coronary arteries in angiography.

Description

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:

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1. Coronary microcirculatory disease	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
2. Epicardial vasospastic angina	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
3. Microvessel vasospastic angina	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
4. Non-cardiac disorder	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
MACCE occurrence	baseline, 12- and 24-month observation
Hospitalization any	baseline, 12- and 24-month observation
symptoms intensity and quality of life (questionnaires)	baseline, 12- and 24-month observation
FMD	baseline, 12- and 24-month observation

Collaborators and Investigators

• Sponsor: Bartlomiej Guzik
• Collaborators: Abbott
• Investigators: Principal Investigator: Bartłomiej Guzik, MD, PhD, John Paul II Hospital, Krakow, Poland; Study Director: Jacek Legutko, MD, PhD, Professor, John Paul II Hospital, Krakow, Poland

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 24, 2020
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): June 30, 2023

Study Registration Dates

• First Submitted: March 29, 2022
• First Submitted That Met QC Criteria: March 29, 2022
• First Posted (ACTUAL): April 6, 2022

Study Record Updates

• Last Update Posted (ACTUAL): April 6, 2022
• Last Update Submitted That Met QC Criteria: March 29, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: ischemic heart disease; coronary artery disease; endothelial dysfunction; coronary microcirculation; microvascular angina; vasospastic angina; coronary microvascular dysfunction; ischemia and no obstructive coronary arteries
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina, Unstable; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Ischemia; Inflammation; Angina Pectoris; Angina Pectoris, Variant; Microvascular Angina; Coronary Stenosis
• Other Study ID Numbers: 304/KBL/OIL2019; PL-2020-01 (OTHER_GRANT: Abbott)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No