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临床试验/NCT02486861
NCT02486861Unknown不适用

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

A.O.U. Città della Salute e della Scienza1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年5月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
the correlation of OCT characteristics with incidence of major adverse cardiovascular events (MACEs) and clinical baseline characteristics.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort

入排标准

性别
All
接受健康志愿者

入选标准

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

排除标准

  • low quality OCT images
  • cardiogenic shock

结局指标

主要结局

the correlation of OCT characteristics with incidence of major adverse cardiovascular events (MACEs) and clinical baseline characteristics.

时间窗: 12 months

次要结局

未报告次要终点

研究者

发起方
A.O.U. Città della Salute e della Scienza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mario Iannaccone

M.D. Cardiology Fellow

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

研究点 (1)

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