Coronary Disease
Conditions
Keywords
Intermediate coronary lesions, Fractional flow reserve, Optical coherence tomography
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: 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.
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.
Interventions
DEVICEOptical coherence tomography (OCT)
Lesion OCT assessment
Sponsors
Catholic University of the Sacred Heart
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with angiographically-intermediate coronary lesion * Patients who underwent both FFR and OCT assessment of the same lesion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| OCT measures predicting FFR - mean lumen area | 1 day | ICL mean lumen area (MLA) |
| OCT measure predicting FFR - area stenosis | 1 day | ICL percentage area stenosis (AS) |
| OCT measure predicting FFR - thrombus or ulceration | 1 day | Presence of thrombus or ulceration at the level of ICL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Cardiac Events (MACE) in untreated patients (no PCI or CABG) | 1 year | Major Adverse Cardiac Events (MACE) defined as the composite of: * cardiac death (any death not clearly attributed to non cardiac causes) * (spontaneous) myocardial infarction (MI) * surgical or percutaneous coronary revascularization of the target lesion (PCI o CABG) |
Countries
Italy
Outcome results
None listed