Ignite Creation Date:
2024-05-06 @ 7:11 AM
Last Modification Date:
2024-10-26 @ 11:45 AM
Study NCT ID:
NCT02486861
Status:
UNKNOWN
Last Update Posted:
2015-07-01
First Post:
2015-06-24
Brief Title:
OCT-Features in Culprit and Not Culprit Coronary Plaque in ACS Patients
Sponsor:
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Organization:
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Study Overview
Official Title:
OCT-Features Of moRphology coMposItion anD instABility of Culprit and Not Culprit Coronary pLaquE in ACS Patients
Status:
UNKNOWN
Status Verified Date:
2015-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OCT-FORMIDABLE
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 datasetThe 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None