OCT Measures Predicting FFR

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.

Official Title
-----------------
OMEF: Optical-coherence-tomography (OCT) Measures Predicting Fractional-flow-reserve (FFR)

Conditions
-----------------
Coronary Disease

Intervention / Treatment
-----------------
* Device: Optical coherence tomography (OCT)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with angiographically-intermediate coronary lesion Patients who underwent both FFR and OCT assessment of the same lesion

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Optical coherence tomography (OCT)<br> | Device: Optical coherence tomography (OCT)<br>* Lesion OCT assessment<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OCT measures predicting FFR - mean lumen area | ICL mean lumen area (MLA) | 1 day | 
| OCT measure predicting FFR - area stenosis | ICL percentage area stenosis (AS) | 1 day | 
| OCT measure predicting FFR - thrombus or ulceration | Presence of thrombus or ulceration at the level of ICL | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiac Events (MACE) in untreated patients (no PCI or CABG) | 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) | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intermediate coronary lesions, Fractional flow reserve, Optical coherence tomography