Evaluating Imaging Techniques for Heart Disease in Patients with Chronic Coronary Syndrome
Multimodality Imaging and Functional Lesion Assessment in Intermediate Grade Coronary Stenosis in Chronic Coronary Syndrome: MultiInter-CCS Study
This study is testing how well two imaging techniques, FFR and OCT, can help people with chronic coronary syndrome and narrowed arteries understand their heart health better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of Warsaw Academic / other |
| Locations | 1 site (Warsaw) |
| Trial ID | NCT06261866 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the diagnostic accuracy of various imaging techniques, specifically fractional flow reserve (FFR) and optical coherence tomography (OCT), in patients with chronic coronary syndrome who have intermediate coronary stenosis. It will analyze the correlation between functional indices and morphometric parameters, such as plaque type and minimal lumen area. The study will also explore how factors like age, sex, diabetes, and renal function affect these correlations. Participants will undergo both FFR and OCT examinations to provide comprehensive data on their coronary health.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with chronic coronary syndrome and intermediate grade coronary stenosis.
Not a fit: Patients with acute coronary syndrome or significant comorbidities such as severe heart failure or acute renal insufficiency may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the diagnostic approach for patients with chronic coronary syndrome, leading to better treatment decisions.
How similar studies have performed: Previous studies have shown promising results using similar imaging techniques for assessing coronary stenosis, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Warsaw
- Medical University of Warsaw — Warsaw, Poland (Recruiting)
Study contacts
- Principal investigator: Mariusz Tomaniak, MD, PhD, Assoc. Prof. — Medical University of Warsaw
- Study coordinator: Mariusz Tomaniak
- Email: mariusz.tomaniak@wum.edu.pl
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.