An observational study in Chronic Coronary Syndrome, sponsored by Medical University of Warsaw. Recruiting at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-15.
Sponsored by Medical University of Warsaw · Observational
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.
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.
302 studies on the registry are indexed under Coronary Stenosis; 63 are open to participants now.
This study's planned enrollment of 200 is close to the median of 200 across 132 observational studies indexed under Coronary Stenosis.
Browse Coronary Stenosis studies →Medical University of Warsaw is the lead sponsor of 316 studies on the registry; 87 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients undergoing coronary angiogram due to chronic coronary syndrome with intermediate grade coronary stenosis.
Exclusion Criteria:
Patients chronic coronary syndrome identified with intermediate grade coronary stenosis undergo coronary angiography according to current practice and guidelines recommendations. FFR will be measured, in consistency with the guidelines and recommended clinical practice. In case of FFR \> 0.8 optimal pharmacotherapy will be prescribed; on the contrary, in case of FFR ≤ 0.8 PCI will be performed. OCT imaging will be performed with commercially available device (Abbott, C7XR Dragonfly TM LightLab Imaging Inc., MA, USA) using the non-occlusive flushing technique.
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
Major adverse cardiovascular events
Time frame: 36 months
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Medical University of Warsaw