OCT-Features in Culprit and Not Culprit Coronary Plaque in ACS Patients

NCT ID: NCT02486861

Last Updated: 2015-07-01

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-05-31

Brief Summary

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.

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.

Conditions

Acute Coronary Syndrome; Culprit Plaque; Non Culprit Plaque

Study Design

• Observational Model Type: COHORT

Study Groups

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.

optical coherence tomography

Intervention Type: OTHER

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.

optical coherence tomography

Intervention Type: OTHER

Interventions

optical coherence tomography

Intervention Type: OTHER

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

A.O.U. Città della Salute e della Scienza

OTHER

Sponsor Role: lead

Responsible Party

Mario Iannaccone

M.D. Cardiology Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mario Iannaccone

Turin, Turin, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Mario Iannaccone, MD

Role: CONTACT

mario.iannaccone@hotmail.it

00390116336023

Facility Contacts

Mario Iannaccone, M.D.

Role: primary

mario.iannaccone@hotmail.it

00390116336023

References

Giordana F, Errigo D, D'Ascenzo F, Montefusco A, Garbo R, Omede P, D'Amico M, Moretti C, Tamburino C, Ferrari GM. Female sex impact on culprit plaque at optical coherence tomography analysis in the setting of acute coronary syndrome in OCT-FORMIDABLE registry. Future Cardiol. 2020 Mar;16(2):123-131. doi: 10.2217/fca-2018-0073. Epub 2020 Jan 22.

Reference Type: DERIVED

PMID: 31965820 (View on PubMed)

Iannaccone M, Souteyrand G, Niccoli G, Mancone M, Sardella G, Tamburino C, Templin C, Gili S, Boccuzzi GG, D'Ascenzo F. Clinical impact of optical coherence tomography findings on culprit plaque in acute coronary syndrome: The OCT-FORMIDABLE study registry. Catheter Cardiovasc Interv. 2018 Dec 1;92(7):E486-E492. doi: 10.1002/ccd.27633. Epub 2018 May 10.

Reference Type: DERIVED

PMID: 29745476 (View on PubMed)

Related Links

http://www.cardiogroup.org

Related Info

Other Identifiers

349/2015

Identifier Type: -

Identifier Source: org_study_id