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NCT Number: NCT06261866

Multimodality Imaging and Functional Lesion Assessment in Intermediate Coronary Stenosis in Chronic Coronary Syndrome

The aim of this prospective, investigator-initiated study is to evaluate the diagnostic accuracy and correlations between functional indices (fractional flow reserve, FFR) and morphometric indices: luminal and qualitative parameters assessed by optical coherence tomography (OCT) including minimal lumen area, plaque type, presence of thin cap fibroatheroma 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

Medical University of Warsaw

Warsaw, Poland

Location status: Recruiting

Location contact

Mariusz Tomaniak, MD, PhD, Assoc. Prof.

CONTACT

[email protected]

Piotr Baruś, MD

CONTACT

[email protected]

About this study

This is a prospective, single center, non-randomized, single-arm, investigator-initiated study evaluating diagnostic accuracy and correlations between functional indices (fractional flow reserve, FFR) and morphometric indices: luminal and qualitative parameters evaluated by OCT including minimal lumen area, plaque stratification into fibrotic, calcific, lipidic plaque, or thin cap fibroatheroma) among patients with chronic coronary syndrome identified with intermediate grade coronary stenosis.

The additional objectives include: evaluation of the impact of age, sex, diabetes mellitus, renal dysfunction on the assocation between functional and morphometric indices of coronary stenosis.

We hypothesized that in patients with intermediate grade coronary stenosis in chronic coronary syndorme there is a positive correlation between the functional parameters and the morphometric parameters of cornary 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
  • FFR and OCT examination of the same lesion
  • 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

Primary outcomes

  1. Correlation between fractional flow reserve (FFR) and minimal lumen area within the coronary stenosis

    Time frame: Baseline

  2. Correlation between fractional flow reserve (FFR) and mean lumen area within the coronary stenosis

    Time frame: Baseline

Secondary outcomes

  1. Major adverse cardiovascular events

    Time frame: 36 months

Study contacts

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

Mariusz Tomaniak

CONTACT

[email protected]

Piotr Baruś

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study title

Multimodality Imaging and Functional Lesion Assessment in Intermediate Grade Coronary Stenosis in Chronic Coronary Syndrome: MultiInter-CCS Study

Acronym: MultiInter-CCS

Important dates

Study start
2011
Primary completion
2024
Study completion
2028
First posted
Feb 15, 2024
Registry last updated
Feb 15, 2024

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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