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

Sponsor
Bartlomiej Guzik (Other)
Overall Status
Recruiting
CT.gov ID
NCT05313919
Collaborator
Abbott (Industry)
160
1
35.2
4.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Comprehensive functional diagnostics of coronary circulation

Study Design

Study Type:
Observational
Anticipated Enrollment :
160 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Coronary Microcirculatory Disease and Inflammation in Patients With Chronic Coronary Syndrome and no Significant Coronary Artery Stenosis. MOSAIC-COR Study.
Actual Study Start Date :
Jul 24, 2020
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Cytokines (serum levels) [baseline]

  2. Diastolic Disfunction parameters in ECHO [baseline, 12- and 24-month follow-up]

Secondary Outcome Measures

  1. MACCE occurrence [baseline, 12- and 24-month observation]

  2. Hospitalization any [baseline, 12- and 24-month observation]

  3. symptoms intensity and quality of life (questionnaires) [baseline, 12- and 24-month observation]

  4. FMD [baseline, 12- and 24-month observation]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
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:

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Interventional Cardiology, John Paul II Hospital, Krakow, Poland, Institute Of Cardiology, Jagiellonian University Medical College Krakow Lesser Poland Poland 31-202

Sponsors and Collaborators

  • Bartlomiej Guzik
  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bartlomiej Guzik, MD, PhD, John Paul II Hospital, Krakow
ClinicalTrials.gov Identifier:
NCT05313919
Other Study ID Numbers:
  • 304/KBL/OIL2019
  • PL-2020-01
First Posted:
Apr 6, 2022
Last Update Posted:
Apr 6, 2022
Last Verified:
Mar 1, 2022

Study Results

No Results Posted as of Apr 6, 2022