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The aim of this prospective, investigator-initiated study is to evaluate the diagnostic accuracy and correlations between mopphometric indices: luminal and qualitative parameters assessed by optical coherence tomography (OCT) including minimal lumen area, plaque type, presence of thin cap fibroatheroma and a functional index - angiography based vessel fractional flow reserve (vFFR) among patients with chronic coronary syndrome identified with intermediate grade coronary stenosis.
This is a prospective, single center, non-randomized, single-arm, investigator-initiated study evaluating diagnostic accuracy and correlations between morphometric indices: luminal and qualitative parameters evaluated by optical coherence tomography (OCT) including minimal lumen area, plaque stratification into fibrotic, calcific, lipidic plaque, or thin cap fibroatheroma and a functional index - angiography based vessel fractional flow reserve (vFFR) among patients with chronic coronary syndrome identified with intermediate grade coronary stenosis.
The additional objectives encompass assessing the influence of age, sex, diabetes mellitus, renal dysfunction on the relationship between vFFR results and morphometric indices of intermediate coronary stenosis.
We hypothesized that in patients with intermediate grade coronary stenosis in chronic coronary syndrome a positive correlation exists between vFFR and the morphometric parameters associated with coronary stenosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing coronary angiogram in chronic coronary syndrome with intermediate stenosis. | Patients undergoing coronary angiogram due to chronic coronary syndrome with intermediate grade coronary stenosis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vessel Fractional Flow Reserve | Diagnostic Test | Optical coherence tomography and vessel fractional flow reserve evaluation of coronary arteries with intermediate to severe stenosis. |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between vessel fractional flow reserve (FFR) and minimal lumen area within the coronary stenosis | Correlation between vessel fractional flow reserve (FFR) and minimal lumen area within the coronary stenosis | 0 days |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiovascular events | Major adverse cardiovascular events | 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing coronary angiogram due to chronic coronary syndrome with intermediate grade coronary stenosis.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mariusz Tomaniak, MD, PhD, Assoc. Prof. | Contact | 0048225991958 | mariusz.tomaniak@wum.edu.pl | |
| Piotr BaruĊ, MD | Contact | piotr.barus@wum.edu.pl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1st Department and Clinic of Cardiology, Medical University of Warsaw | Recruiting | Warsaw | Mazowieckie Voivodenship | 02-097 | Poland |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D023921 | Coronary Stenosis |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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