OCT Measures Predicting FFR

Coronary Disease Clinical Trial

— OMEF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03573388
• Other study ID #: 20042018
• Status: Completed
• Start date: October 16, 2017
• Est. completion date: February 18, 2018

Study information

• Verified date: June 2018
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: February 18, 2018
• Est. primary completion date: October 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with angiographically-intermediate coronary lesion

• Patients who underwent both FFR and OCT assessment of the same lesion

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease

Intervention

Device:
• Optical coherence tomography (OCT)
Lesion OCT assessment

Locations

Country	Name	City	State
Italy	Policlinico A. Gemelli. Università Cattolica del Sacro Cuore	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OCT measures predicting FFR - mean lumen area	ICL mean lumen area (MLA)	1 day
Primary	OCT measure predicting FFR - area stenosis	ICL percentage area stenosis (AS)	1 day
Primary	OCT measure predicting FFR - thrombus or ulceration	Presence of thrombus or ulceration at the level of ICL	1 day
Secondary	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