Vessel Imaging Using Optical Coherence Tomography for Plaque Morphology and Vessel Fractional Flow Reserve
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: vessel Fractional Flow Reserve.
- Who it may be relevant to
- Registry conditions: Coronary Artery Disease, Coronary Artery Stenosis, Tomography, Optical Coherence, 3D-angio-based FFR. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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 test vessel Fractional Flow Reserve
Optical coherence tomography and vessel fractional flow reserve evaluation of coronary arteries with intermediate to severe stenosis.
Primary outcome measures
- Correlation between vessel fractional flow reserve (FFR) and minimal lumen area within the coronary stenosis [Time frame: 0 days]
Secondary outcome measures (1)
- Major adverse cardiovascular events [Time frame: 36 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Poland · 1 center
- 1st Department and Clinic of Cardiology, Medical University of Warsaw — Warsaw
Identifiers
NCT: NCT06844942 · VISION-FFR