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Completed

NCT Number: NCT03573388

OCT Measures Predicting 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.

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Key information

Conditions

Coronary Disease Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Policlinico A. Gemelli. Università Cattolica del Sacro Cuore

Roma, 00168, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Optical coherence tomography (OCT)

Device

Lesion OCT assessment

Primary outcomes

  1. OCT measures predicting FFR - mean lumen area

    Time frame: 1 day

    ICL mean lumen area (MLA)

  2. OCT measure predicting FFR - area stenosis

    Time frame: 1 day

    ICL percentage area stenosis (AS)

  3. OCT measure predicting FFR - thrombus or ulceration

    Time frame: 1 day

    Presence of thrombus or ulceration at the level of ICL

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Catholic University of the Sacred Heart

Other

Registry information

Official study title

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

Acronym: OMEF

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Jun 29, 2018
Registry last updated
Jun 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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