OCT Measures Predicting FFR

Completed

• Conditions: Coronary Disease
• Interventions: Device: Optical coherence tomography (OCT)

• Registration Number: NCT03573388
• Lead Sponsor: Catholic University of the Sacred Heart

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.

Study Timeline

• Study Start: 2017-10-16
• Primary Completion: 2017-10-30
• Study Completion: 2018-02-18
• Study First Submitted: 2018-04-23
• Status Verified: 2018-06
• Study First Submitted QC: 2018-06-19
• Last Update Submitted: 2018-06-19
• Study First Posted: 2018-06-29
• Last Update Posted: 2018-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Patients with angiographically-intermediate coronary lesion
• Patients who underwent both FFR and OCT assessment of the same lesion

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Optical coherence tomography (OCT)	Optical coherence tomography (OCT)	-

Primary Outcome Measures

Name	Time	Method
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
OCT measures predicting FFR - mean lumen area	1 day	ICL mean lumen area (MLA)

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Policlinico A. Gemelli. Università Cattolica del Sacro Cuore; 🇮🇹 Roma, Italy