OMEF: Optical-coherence-tomography (OCT) Measures Predicting Fractional-flow-reserve (FFR)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- OCT measure predicting FFR - area stenosis
Study Overview
Brief Summary
Background: the decision-making process of patients with angiographically-intermediate coronary lesions (ICL) is clinically challenging and may benefit from adjunctive invasive techniques. Fractional-flow-reserve (FFR) represents the gold standard to evaluate ICL but optical-coherence-tomography (OCT) is a novel, promising, high resolution coronary imaging technique.
Objectives:
- Investigate the relation between OCT and FFR parameters in ICL and understand if OCT measures may predict FFR.
- Understand if OCT parameters may predict clinical outcome of patients with ICL not underwent revascularization on the bases of negative FFR.
Study design: multicentre, international, individual patient's level data pooled analysis.
Detailed Description
Principal investigators that enrolled stable or unstable patients with ICL who underwent both FFR and OCT assessment of the same lesion, will be contacted to participate the study. Agreeing investigators will be asked to complete a structured database by providing a series of key baseline clinical and angiographic data, OCT and FFR parameters.
Collected dataset will include: sex, age, hypertension, diabetes, hypercholesterolemia, current smoking, family history of CAD, clinical presentation, previous PCI, previous MI, previous CABG, non-invasive ischemia, angina, n° of diseased vessels, diseased vessel, percentage diameter stenosis at quantitative coronary angiography (QCA% stenosis), length of stenosis at quantitative coronary angiography, presence of thrombus or ulceration, MLA, area stenosis at OCT, FFR protocol (intracoronary adenosine, endovenous adenosine, contrast) results and long term clinical follow-up.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with angiographically-intermediate coronary lesion
- •Patients who underwent both FFR and OCT assessment of the same lesion
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
OCT measure predicting FFR - area stenosis
Time Frame: 1 day
ICL percentage area stenosis (AS)
OCT measure predicting FFR - thrombus or ulceration
Time Frame: 1 day
Presence of thrombus or ulceration at the level of ICL
OCT measures predicting FFR - mean lumen area
Time Frame: 1 day
ICL mean lumen area (MLA)
Secondary Outcomes
- Major Adverse Cardiac Events (MACE) in untreated patients (no PCI or CABG)(1 year)
Investigators
Francesco Burzotta
MD, PhD
Catholic University of the Sacred Heart