OCT-Features in Culprit and Not Culprit Coronary Plaque in ACS Patients (OCT-FORMIDABLE)

June 29, 2015 updated by: Mario Iannaccone, Azienda Ospedaliera Città della Salute e della Scienza di Torino

OCT-Features Of moRphology, coMposItion anD instABility of Culprit and Not Culprit Coronary pLaquE in ACS Patients

The OCT-FORMIDABLE register will include with a retrospective fashion all consecutive patients that perform OCT on culprit and not culprit plaque in any subset in patients with ACS. Clinical and OCT data will be included in the register according to the dataset.The primary endpoint will be the correlation of OCT characteristics with incidence of major adverse cardiovascular events (MACEs defined as the composite of death from cardiac causes, non- fatal MI, clinically driven target vessel revascularization (TVR), or re-hospitalization due to unstable or progressive angina according to Braunwald Unstable Angina Classification) and clinical baseline characteristics.

In particular subanalysis will be performed in the following subgroups: culprit plaque, not culprit plaque in culprit vessel, not culprit plaque in different vessel.

Secondary end-point will be to evaluate how OCT analysis changed interventional cardiology approach in culprit plaque definition and coronary stenting respect the coronary angiography alone.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

INTRODUCTION. Pathophysiology of Acute Coronary Syndrome (ACS) deeply differs from those of stable patients, mainly due to peculiar features of plaque. Interestingly, most of the lesions triggering an acute ischemic event, usually defined "culprit lesions" are not angiographically severe, but present with mild stenosis. However, when evaluated at autopsy or with intracoronary imaging, they show often a pro-thrombotic pattern, with thin cap fibroatheroma, soft plaques and thrombus, prone to rupture.

Patients without culprit plaque rupture (CPR) exhibit different mechanisms of instability including thrombus at the site of plaque erosion, or intense vasoconstriction of epicardial arteries or coronary microcirculation disfunction.

In this setting, in the last years Optical Coherence Tomography (OCT) has emerged as the most accurate instrument for intracoronary evaluation. Due to a resolution of approximately 10-20 µm it has been largely exploited in the evaluation and characterization of plaque features, both in stable and acute coronary artery disease.

On the other hand, despite recent evidences, characteristics of culprit plaque in different subset of patients are not well defined. Moreover clinical significance of plaque characteristics is unknown.

METHODS The OCT-FORMIDABLE register will include with a retrospective fashion all consecutive patients that perform OCT on culprit and not culprit plaque in any subset in patients with ACS. Clinical and OCT data will be included in the register according to the dataset.

SAMPLE SIZE: the recent paper of Niccoli et al showed a percentages of plaque rupture of 60% in ACS. According to the paper by Pedruzzi et al, at least 100 patients are needed to evaluate independent predictive power of clinical presentation (STEMI vs NSTEMI vs UA), diabetes mellitus, previous use of aspirin, of statin and age.

OCT ANALYSIS Different OCT system analysis and technique (different pullback velocity 75 mm vs 54 mm, contrast mediated or ringer lactate injection) will be reported. Each center will evaluate the OCT image by internal committee composed by at least two people. In case of discordance an external opinion will be required.

Plaque rupture will be defined as the presence of fibrous cap discontinuity leading to a communication between the inner (necrotic) core of the plaque and the lumen. Plaque rupture included also fibrous cap disruption detected over a calcified plaque characterized by protruding calcification, superficial calcium, and the presence of substantive calcium proximal or distal to the lesion.

Thin cap fibro atheroma will be defined as cap thickness < 65 nm. Thin cap fibro atheroma at rupture site will be reported.

Fibrocalcific, fibrotic plaque, lipid component or macrophage infiltration will be defined according to the recent proposed criteria and reported.

Data will be divided according the clinical significance of the studied plaque, in particular culprit plaque, not culprit plaque in culprit vessel and not culprit plaque in other vessels.

Moreover will be recoded if OCT analysis changed the interventional cardiologist approach in deciding the culprit lesion to treat.

CLINICAL FOLLOW-UP AND ENDPOINT DEFINITION A clinical follow-up at least of 12 months after discharge will be evaluated.

The primary endpoint will be the correlation of OCT characteristics with incidence of major adverse cardiovascular events (MACEs defined as the composite of death from cardiac causes, non- fatal MI, clinically driven target vessel revascularization (TVR), or re-hospitalization due to unstable or progressive angina according to Braunwald Unstable Angina Classification) and clinical baseline characteristics.

In particular subanalysis will be performed in the following subgroups: culprit plaque, not culprit plaque in culprit vessel, not culprit plaque in different vessel.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

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

Study Contact

Study Locations

  • Italy
      • Turin, Italy, 10100
        • Recruiting
        • Mario Iannaccone
        • Principal Investigator:
          • Claudio Moretti, MD
        • Contact:
        • Sub-Investigator:
          • Fabrizio Ugo, MD
        • Sub-Investigator:
          • Giuseppe Biondi-Zoccai, Prof.
        • Sub-Investigator:
          • Giampaolo Niccoli, Prof.
        • Sub-Investigator:
          • Francesco Saia, Prof.
        • Sub-Investigator:
          • France Souteyrand, MD
        • Sub-Investigator:
          • Kostantinos Toutouzas, Prof.
        • Sub-Investigator:
          • Massimo Mancone, Prof.

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The OCT-FORMIDABLE register will include with a retrospective fashion all consecutive patients that perform OCT on culprit and not culprit plaque in any subset in patients with ACS. Clinical and OCT data will be included in the register according to the dataset.

SAMPLE SIZE: the recent paper of Niccoli et al11 showed a percentages of plaque rupture of 60% in ACS. According to the paper of Pedruzzi et al12, at least 100 patients are needed to evaluate independent predictive power of clinical presentation (STEMI vs NSTEMI vs UA), diabetes mellitus, previous use of aspirin, of statin and age.

Description

Inclusion Criteria:

  • all consecutive patients that perform OCT on culprit and not culprit plaque in any subset in patients with ACS.

Exclusion Criteria:

  • low quality OCT images
  • cardiogenic shock

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
culprit plaque
correlation of OCT characteristics of culprit plaque with incidence of major adverse cardiovascular events (MACEs defined as the composite of death from cardiac causes, non- fatal MI, clinically driven target vessel revascularization (TVR), or re-hospitalization due to unstable or progressive angina according to Braunwald Unstable Angina Classification) and clinical baseline characteristics.
Other: optical coherence tomography
non culprit plaque
correlation of OCT characteristics of non culprit plaque of culprit plaque with incidence of major adverse cardiovascular events (MACEs defined as the composite of death from cardiac causes, non- fatal MI, clinically driven target vessel revascularization (TVR), or re-hospitalization due to unstable or progressive angina according to Braunwald Unstable Angina Classification) and clinical baseline characteristics.
Other: optical coherence tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the correlation of OCT characteristics with incidence of major adverse cardiovascular events (MACEs) and clinical baseline characteristics.
Time Frame: 12 months
12 months

Collaborators and Investigators

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

Sponsor

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

May 1, 2015

Primary Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

June 24, 2015

First Submitted That Met QC Criteria

June 29, 2015

First Posted (Estimate)

July 1, 2015

Study Record Updates

Last Update Posted (Estimate)

July 1, 2015

Last Update Submitted That Met QC Criteria

June 29, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 349/2015

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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