Evaluating vessel imaging for coronary artery disease
Vessel Imaging Using Optical Coherence Tomography for Plaque Morphology and Vessel Fractional Flow Reserve
Medical University of Warsaw · NCT06844942
This study is testing if a special imaging technique can help doctors better understand plaque in the arteries of people with heart issues and see how it relates to blood flow.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of Warsaw (other) |
| Locations | 1 site (Warsaw, Mazowieckie Voivodenship) |
| Trial ID | NCT06844942 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the diagnostic accuracy of optical coherence tomography (OCT) in evaluating plaque morphology and its correlation with vessel fractional flow reserve (vFFR) in patients with chronic coronary syndrome and intermediate grade coronary stenosis. It will analyze morphometric indices such as minimal lumen area and plaque type, including thin cap fibroatheroma. The study will also explore how factors like age, sex, diabetes, and renal dysfunction influence the relationship between vFFR and these morphometric parameters. Participants will undergo OCT and angiography to gather data for this analysis.
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, severe heart failure, or other significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the diagnostic accuracy for assessing coronary artery disease and guide treatment decisions.
How similar studies have performed: Similar studies using optical coherence tomography for coronary assessments have shown promising results, 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 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
Where this trial is running
Warsaw, Mazowieckie Voivodenship
- 1st Department and Clinic of Cardiology, Medical University of Warsaw — Warsaw, Mazowieckie Voivodenship, Poland (RECRUITING)
Study contacts
- Study coordinator: Mariusz Tomaniak, MD, PhD, Assoc. Prof.
- Email: mariusz.tomaniak@wum.edu.pl
- Phone: 0048225991958
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.
Conditions: Coronary Artery Disease, Coronary Artery Stenosis, Tomography, Optical Coherence, 3D-angio-based FFR