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The aim of this prospective, investigator-initiated study is to evaluate the diagnostic accuracy and correlations between functional indices (fractional flow reserve, FFR) and morphometric indices: luminal and qualitative parameters assessed by optical coherence tomography (OCT) including minimal lumen area, plaque type, presence of thin cap fibroatheroma 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 functional indices (fractional flow reserve, FFR) and morphometric indices: luminal and qualitative parameters evaluated by OCT including minimal lumen area, plaque stratification into fibrotic, calcific, lipidic plaque, or thin cap fibroatheroma) among patients with chronic coronary syndrome identified with intermediate grade coronary stenosis.
The additional objectives include: evaluation of the impact of age, sex, diabetes mellitus, renal dysfunction on the assocation between functional and morphometric indices of coronary stenosis.
We hypothesized that in patients with intermediate grade coronary stenosis in chronic coronary syndorme there is a positive correlation between the functional parameters and the morphometric parameters of cornary stenosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with chronic coronary syndromes identified with intermediate grade coronary stenosis | Patients chronic coronary syndrome identified with intermediate grade coronary stenosis undergo coronary angiography according to current practice and guidelines recommendations. FFR will be measured, in consistency with the guidelines and recommended clinical practice. In case of FFR > 0.8 optimal pharmacotherapy will be prescribed; on the contrary, in case of FFR ≤ 0.8 PCI will be performed. OCT imaging will be performed with commercially available device (Abbott, C7XR Dragonfly TM LightLab Imaging Inc., MA, USA) using the non-occlusive flushing technique. |
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| Measure | Description | Time Frame |
|---|---|---|
| Correlation between fractional flow reserve (FFR) and minimal lumen area within the coronary stenosis | Baseline | |
| Correlation between fractional flow reserve (FFR) and mean lumen area within the coronary stenosis | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Contact | mariusz.tomaniak@wum.edu.pl | ||
| Piotr Baruś | Contact | piotr.barus@wum.edu.pl |
| Name | Affiliation | Role |
|---|---|---|
| Mariusz Tomaniak, MD, PhD, Assoc. Prof. | Medical University of Warsaw | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Warsaw | Recruiting | Warsaw | Poland |
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