3D-angio-based FFR, Coronary Artery Disease, Coronary Artery Stenosis, Tomography, Optical Coherence
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTvessel Fractional Flow Reserve
Optical coherence tomography and vessel fractional flow reserve evaluation of coronary arteries with intermediate to severe stenosis.
Sponsors
Medical University of Warsaw
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older * Chronic coronary syndrome defined as presence of chest pain ranked 2-3 in the Canadian Cardiovascular Society classification or positive ischemia test (exercise test, single photon emission tomography (SPECT) * Intermediate grade coronary stenosis of 40-80% assessed visually in coronary angiography and OCT examination The patient is willing to participate in the study and has provided a written informed consent
Exclusion criteria
* Acute coronary syndrome * Proximal left main lesion * Ostial right coronary artery lesion * Bypass of the assessed vessel * Contraindications for adenosine administration * Hemodynamic instability * Heart insufficiency in New York Heart Association (NYHA) class IV scale * Acute renal insufficiency * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between vessel fractional flow reserve (FFR) and minimal lumen area within the coronary stenosis | 0 days | Correlation between vessel fractional flow reserve (FFR) and minimal lumen area within the coronary stenosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiovascular events | 36 months | Major adverse cardiovascular events |
Countries
Poland
Contacts
Primary ContactMariusz Tomaniak, MD, PhD, Assoc. Prof.
Backup ContactPiotr Baruś, MD
Outcome results
None listed