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NCT Number: NCT06844942

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Warsaw, Mazowieckie Voivodenship, 02-097, Poland

Location status: Recruiting

Location contact

Mariusz Tomaniak, MD, PhD, Assoc. Prof.

CONTACT

[email protected]

+48 22 599-19-58

Mariusz Tomaniak, MD, PhD, Assoc. Prof.

PRINCIPAL_INVESTIGATOR

Piotr Baruś, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

vessel Fractional Flow Reserve

Diagnostic Test

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Major adverse cardiovascular events

    Time frame: 36 months

    Major adverse cardiovascular events

Study contacts

Contact information is provided by the study sponsor or research team.

Mariusz Tomaniak, MD, PhD, Assoc. Prof.

CONTACT

[email protected]

0048225991958

Piotr Baruś, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Acronym: VISION-FFR

Important dates

Study start
2020
Primary completion
2027
Study completion
2029
First posted
Feb 25, 2025
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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