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

NCT ID: NCT06844942

Last Updated: 2025-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-20

Study Completion Date

2029-01-31

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease Coronary Artery Stenosis Tomography, Optical Coherence 3D-angio-based FFR

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients undergoing coronary angiogram in chronic coronary syndrome with intermediate stenosis.

Patients undergoing coronary angiogram due to chronic coronary syndrome with intermediate grade coronary stenosis.

vessel Fractional Flow Reserve

Intervention Type DIAGNOSTIC_TEST

Optical coherence tomography and vessel fractional flow reserve evaluation of coronary arteries with intermediate to severe stenosis.

Interventions

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vessel Fractional Flow Reserve

Optical coherence tomography and vessel fractional flow reserve evaluation of coronary arteries with intermediate to severe stenosis.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Warsaw

OTHER

Sponsor Role lead

Responsible Party

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Mariusz Tomaniak

Mariusz Tomaniak, MD, PhD, Assoc. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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1st Department and Clinic of Cardiology, Medical University of Warsaw

Warsaw, Mazowieckie Voivodenship, Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Mariusz Tomaniak, MD, PhD, Assoc. Prof.

Role: CONTACT

0048225991958

Piotr BaruĊ›, MD

Role: CONTACT

Facility Contacts

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Mariusz Tomaniak, MD, PhD, Assoc. Prof.

Role: primary

+48 22 599-19-58

Other Identifiers

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VISION-FFR

Identifier Type: -

Identifier Source: org_study_id

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