Vessel Imaging Using Optical Coherence Tomography for Plaque Morphology and Vessel Fractional Flow Reserve (VISION-FFR)

February 19, 2025 updated by: Mariusz Tomaniak, Medical University of Warsaw
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Poland
    • Mazowieckie Voivodenship
      • Warsaw, Mazowieckie Voivodenship, Poland, 02-097
        • Recruiting
        • 1st Department and Clinic of Cardiology, Medical University of Warsaw
        • Contact:
        • Contact:
          • Mariusz Tomaniak, MD, PhD, Assoc. Prof.
        • Contact:
          • Piotr Baruś, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Diagnostic test: vessel Fractional Flow Reserve
Optical coherence tomography and vessel fractional flow reserve evaluation of coronary arteries with intermediate to severe stenosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between vessel fractional flow reserve (FFR) and minimal lumen area within the coronary stenosis
Time Frame: 0 days
Correlation between vessel fractional flow reserve (FFR) and minimal lumen area within the coronary stenosis
0 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiovascular events
Time Frame: 36 months
Major adverse cardiovascular events
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2020

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

January 31, 2029

Study Registration Dates

First Submitted

February 19, 2025

First Submitted That Met QC Criteria

February 19, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 19, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VISION-FFR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe