Clinical trial NCT06844942: Vessel Imaging Using Optical Coherence Tomography for Plaque Morphology and Vessel Fractional Flow Reserve
Official title: Vessel Imaging Using Optical Coherence Tomography for Plaque Morphology and Vessel Fractional Flow Reserve
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Coronary Artery Stenosis
Tomography, Optical Coherence
3D-angio-based FFR
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2025-02-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing coronary angiogram due to chronic coronary syndrome with intermediate grade coronary stenosis.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Correlation between vessel fractional flow reserve (FFR) and minimal lumen area within the coronary stenosis
timeFrame: 0 days
Secondary outcomes:
measure: Major adverse cardiovascular events
timeFrame: 36 months
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: 1st Department and Clinic of Cardiology, Medical University of Warsaw
state: Mazowieckie Voivodenship
Study officials:
References: