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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06261866

Acronym

MultiInter-CCS

Enrollment

200

Registered

2024-02-15

Start date

2011-04-07

Completion date

2028-12-31

Last updated

2024-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Coronary Syndrome

Keywords

FFR, OCT, IVUS, CCS

Brief summary

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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Correlation between fractional flow reserve (FFR) and mean lumen area within the coronary stenosis	Baseline
Correlation between fractional flow reserve (FFR) and minimal lumen area within the coronary stenosis	Baseline

Secondary

Measure	Time frame
Major adverse cardiovascular events	36 months

Countries

Poland

Contacts

Primary ContactMariusz Tomaniak

mariusz.tomaniak@wum.edu.pl

Backup ContactPiotr Baruś

piotr.barus@wum.edu.pl

Outcome results