OCT Measures Predicting FFR (OMEF)

June 19, 2018 updated by: Francesco Burzotta, Catholic University of the Sacred Heart

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Roma, Italy, 00168
        • Policlinico A. Gemelli. Università Cattolica del Sacro Cuore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Stable or unstable patients with intermediate coronary lesions who underwent both FFR and OCT assessment of the same lesion

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Optical coherence tomography (OCT)
Device: Optical coherence tomography (OCT)
Lesion OCT assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OCT measures predicting FFR - mean lumen area
Time Frame: 1 day
ICL mean lumen area (MLA)
1 day
OCT measure predicting FFR - area stenosis
Time Frame: 1 day
ICL percentage area stenosis (AS)
1 day
OCT measure predicting FFR - thrombus or ulceration
Time Frame: 1 day
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)
Time Frame: 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)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catholic University of the Sacred Heart

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 16, 2017

Primary Completion (ACTUAL)

October 30, 2017

Study Completion (ACTUAL)

February 18, 2018

Study Registration Dates

First Submitted

April 23, 2018

First Submitted That Met QC Criteria

June 19, 2018

First Posted (ACTUAL)

June 29, 2018

Study Record Updates

Last Update Posted (ACTUAL)

June 29, 2018

Last Update Submitted That Met QC Criteria

June 19, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20042018

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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