Vessel Imaging Using Optical Coherence Tomography for Plaque Morphology and Vessel Fractional Flow Reserve

Recruiting

• Conditions: Coronary Artery Disease; Tomography, Optical Coherence; Coronary Artery Stenosis; 3D-angio-based FFR

• Registration Number: NCT06844942
• Lead Sponsor: Medical University of Warsaw

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.

Study Timeline

• Study Start: 2020-09-20
• Status Verified: 2025-02
• Study First Submitted: 2025-02-19
• Study First Submitted QC: 2025-02-19
• Last Update Submitted: 2025-02-19
• Study First Posted: 2025-02-25
• Last Update Posted: 2025-02-25
• Primary Completion: 2027-12-31
• Study Completion: 2029-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Major adverse cardiovascular events	36 months	Major adverse cardiovascular events

Trial Locations

Locations (1)

1st Department and Clinic of Cardiology, Medical University of Warsaw; 🇵🇱 Warsaw, Mazowieckie Voivodenship, Poland