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OCT Measures Predicting FFR

NCT ID: NCT03573388

Last Updated: 2018-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-16

Study Completion Date

2018-02-18

Brief Summary

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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

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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.

Conditions

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Coronary Disease

Keywords

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Intermediate coronary lesions Fractional flow reserve Optical coherence tomography

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Optical coherence tomography (OCT)

Optical coherence tomography (OCT)

Intervention Type DEVICE

Lesion OCT assessment

Interventions

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Optical coherence tomography (OCT)

Lesion OCT assessment

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients with angiographically-intermediate coronary lesion
* Patients who underwent both FFR and OCT assessment of the same lesion
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Catholic University of the Sacred Heart

OTHER

Sponsor Role lead

Responsible Party

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Francesco Burzotta

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Policlinico A. Gemelli. Università Cattolica del Sacro Cuore

Roma, , Italy

Site Status

Countries

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Italy

References

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Lombardi M, Vergallo R, Costantino A, Bianchini F, Kakuta T, Pawlowski T, Leone AM, Sardella G, Agostoni P, Hill JM, De Maria GL, Banning AP, Roleder T, Belkacemi A, Trani C, Burzotta F. Development of machine learning models for fractional flow reserve prediction in angiographically intermediate coronary lesions. Catheter Cardiovasc Interv. 2024 Sep;104(3):472-482. doi: 10.1002/ccd.31167. Epub 2024 Aug 1.

Reference Type DERIVED
PMID: 39091119 (View on PubMed)

Other Identifiers

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20042018

Identifier Type: -

Identifier Source: org_study_id