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| ID | Type | Description | Link |
|---|---|---|---|
| PL-2020-01 | Other Grant/Funding Number | Abbott |
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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. Coronary microcirculatory disease |
| ||
| 2. Epicardial vasospastic angina |
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| 3. Microvessel vasospastic angina |
| ||
| 4. Non-cardiac disorder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comprehensive functional diagnostics of coronary circulation | Diagnostic Test | Comprehensive functional diagnostics of coronary circulation in patients with INOCA (ischemia and no obstructive coronary arteries) including:
|
| Measure | Description | Time Frame |
|---|---|---|
| Cytokines (serum levels) | baseline | |
| Diastolic Disfunction parameters in ECHO | baseline, 12- and 24-month follow-up |
| Measure | Description | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with symptomatic chronic coronary syndrome and no significant lesions in epicardial coronary arteries in angiography.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bartłomiej Guzik, MD, PhD | Contact | +48 614 35 01 | b.guzik@uj.edu.pl | |
| Piotr Szolc, MD | Contact | +48 614 35 01 | piotr.szolc4@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Bartłomiej Guzik, MD, PhD | John Paul II Hospital, Krakow, Poland | Principal Investigator |
| Jacek Legutko, MD, PhD, Professor | John Paul II Hospital, Krakow, Poland | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Interventional Cardiology, John Paul II Hospital, Krakow, Poland, Institute Of Cardiology, Jagiellonian University Medical College | Recruiting | Krakow | Lesser Poland Voivodeship | 31-202 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41826400 | Derived | Stapor M, Bernacik A, Szolc P, Niewiara L, Guzik B, Kleczynski P, Diachyshyn M, Zmudka K, Legutko J. Prevalence of heart failure with preserved ejection fraction in patients with ischemia and non-obstructive coronary arteries. Sci Rep. 2026 Mar 13;16(1):16626. doi: 10.1038/s41598-026-42032-x. |
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|
| baseline, 12- and 24-month observation |
| FMD | baseline, 12- and 24-month observation |
|
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D007511 | Ischemia |
| D017202 | Myocardial Ischemia |
| D017566 | Microvascular Angina |
| D000788 | Angina Pectoris, Variant |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000787 | Angina Pectoris |
| D000789 | Angina, Unstable |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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