Multimodality Imaging and Functional Lesion Assessment in Intermediate Coronary Stenosis in Chronic Coronary Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Chronic Coronary Syndrome. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Multimodality Imaging and Functional Lesion Assessment in Intermediate Grade Coronary Stenosis in Chronic Coronary Syndrome: MultiInter-CCS Study
Overview
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.
Primary outcome measures
- Correlation between fractional flow reserve (FFR) and minimal lumen area within the coronary stenosis [Time frame: Baseline]
- Correlation between fractional flow reserve (FFR) and mean lumen area within the coronary stenosis [Time frame: Baseline]
Secondary outcome measures (1)
- Major adverse cardiovascular events [Time frame: 36 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Poland · 1 center
- Medical University of Warsaw — Warsaw
Identifiers
NCT: NCT06261866 · MultiInter-CCS