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Clinical Trials/NCT05313919
NCT05313919
Unknown
Not Applicable

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

Bartlomiej Guzik1 site in 1 country160 target enrollmentJuly 24, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
Bartlomiej Guzik
Enrollment
160
Locations
1
Primary Endpoint
Diastolic Disfunction parameters in ECHO
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 24, 2020
End Date
June 30, 2023
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Bartlomiej Guzik
Responsible Party
Sponsor Investigator
Principal Investigator

Bartlomiej Guzik

MD, PhD

John Paul II Hospital, Krakow

Eligibility Criteria

Inclusion Criteria

  • Diagnosed chronic coronary syndrome CCS ≥
  • Evidence of myocardial ischemia (positive result of non-invasive stress test).
  • Informed consent.
  • Age at least 18 years.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Diastolic Disfunction parameters in ECHO

Time Frame: baseline, 12- and 24-month follow-up

Cytokines (serum levels)

Time Frame: baseline

Secondary Outcomes

  • 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)

Study Sites (1)

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