Actively Recruiting
Vessel Imaging Using Optical Coherence Tomography for Plaque Morphology and Vessel Fractional Flow Reserve
Led by Medical University of Warsaw · Updated on 2025-02-25
200
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the relationship between vessel fractional flow reserve (vFFR) and plaque characteristics in patients with chronic coronary syndrome who have intermediate grade coronary artery stenosis. This prospective, investigator-initiated study evaluates how well optical coherence tomography (OCT) measurements of plaque morphology and minimal lumen area correlate with vFFR, a functional index derived from angiography. The study also explores how factors like age, sex, diabetes, and kidney function affect these relationships. Participants undergo coronary angiograms and OCT to assess the coronary arteries with intermediate stenosis ranging from 40% to 80%. The study is a single-center, non-randomized, single-arm observational design where all patients receive diagnostic evaluations including OCT and vessel fractional flow reserve measurements. These methods focus on assessing plaque types such as fibrotic, calcific, lipidic, and thin cap fibroatheroma. During the study, participants provide written informed consent and are monitored for correlations between vFFR and minimal lumen area at the time of their procedure. Follow-up includes tracking major adverse cardiovascular events over 36 months. The study collects detailed imaging, clinical data, and patient history to better understand coronary artery disease in this population, with ongoing safety and health assessments throughout the study period.
CONDITIONS
Brief Title
Vessel Imaging Using Optical Coherence Tomography for Plaque Morphology and Vessel Fractional Flow Reserve
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older
- Diagnosed with chronic coronary syndrome characterized by chest pain ranked 2 or 3 on the Canadian Cardiovascular Society scale or a positive ischemia test
- Presence of intermediate grade coronary stenosis between 40% and 80% as assessed by coronary angiography and optical coherence tomography
- Willing to participate and provide written informed consent
You will not qualify if you...
- Acute coronary syndrome
- Proximal left main coronary artery lesion
- Ostial right coronary artery lesion
- History of bypass surgery on the assessed vessel
- Contraindications for adenosine administration
- Hemodynamic instability
- Heart failure classified as New York Heart Association class IV
- Acute kidney failure
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo optical coherence tomography and vessel fractional flow reserve evaluation of coronary arteries with intermediate to severe stenosis.
1 visit (in-person)
Duration - Up to 36 months
Participants are monitored for major adverse cardiovascular events following the diagnostic evaluation.
Follow-up visits as per routine clinical care
Trial Site Locations
Total: 1 location
1
1st Department and Clinic of Cardiology, Medical University of Warsaw
Warsaw, Mazowieckie Voivodenship, Poland, 02-097
Actively Recruiting
Research Team
M
Mariusz Tomaniak, MD, PhD, Assoc. Prof.
P
Piotr Baruś, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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