Coronary Disease Clinical Trial
Official title:
OMEF: Optical-coherence-tomography (OCT) Measures Predicting Fractional-flow-reserve (FFR)
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:
1. Investigate the relation between OCT and FFR parameters in ICL and understand if OCT
measures may predict FFR.
2. 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.
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.
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