Clinical trial NCT05313919: Coronary Microcirculatory Disease and Inflammation in Patients With Chronic Coronary Syndrome and no Significant Coronary Artery Stenosis
Official title: Coronary Microcirculatory Disease and Inflammation in Patients With Chronic Coronary Syndrome and no Significant Coronary Artery Stenosis. MOSAIC-COR Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Ischemia and No Obstructive Coronary Arteries
Ischemic Heart Disease
Microvascular Angina
Vasospastic Angina
Keywords: coronary artery disease
ischemia and no obstructive coronary arteries
ischemic heart disease
microvascular angina
vasospastic angina
coronary microvascular dysfunction
coronary microcirculation
endothelial dysfunction
Lead sponsor: John Paul II Hospital, Krakow
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2022-04-06
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with symptomatic chronic coronary syndrome and no significant lesions in epicardial coronary arteries in angiography.

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.


Eligibility criteria: 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:

Primary outcomes:
measure: Cytokines (serum levels)
timeFrame: baseline
measure: Diastolic Disfunction parameters in ECHO
timeFrame: baseline, 12- and 24-month follow-up
Secondary outcomes:
measure: MACCE occurrence
timeFrame: baseline, 12- and 24-month observation
measure: Hospitalization any
timeFrame: baseline, 12- and 24-month observation
measure: symptoms intensity and quality of life (questionnaires)
timeFrame: baseline, 12- and 24-month observation
measure: FMD
timeFrame: baseline, 12- and 24-month observation
Other outcomes:
Locations:
city: Krakow
country: Poland
facility: Department of Interventional Cardiology, John Paul II Hospital, Krakow, Poland, Institute Of Cardiology, Jagiellonian University Medical College
state: Lesser Poland
Study officials:
affiliation: John Paul II Hospital, Krakow, Poland
name: Bartłomiej Guzik, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: John Paul II Hospital, Krakow, Poland
name: Jacek Legutko, MD, PhD, Professor
role: STUDY_DIRECTOR
References: