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临床试验/NCT01437553
NCT01437553已完成不适用

Registry Using IVUS and iMAP to Evaluate Atherosclerotic Coronary Plaque in Acute Coronary Syndromes

Federal University of São Paulo1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2011年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Atherosclerotic plaque composition

研究概览

简要总结

The iWONDER trial has the following objective:

To analyze the morphological, phenotypic and tissue characteristics of atherosclerotic plaques angiographically considered "culprit" and "not-culprit" in patients undergoing coronary angiography due to STEMI (ST-elevation myocardial infarction).

详细描述

Coronary artery angiography (CA) is a two-dimensional silhouette of the arterial lumen from a complex three dimensional vascular structure. This exam has several limitations already well documented, including shortening of the vessel, overlapping images, intra and inter-observer variability during the consideration of the severity of injuries. Besides, it offers great limitations in the diagnosis of the composition of atherosclerotic plaque. Furthermore, intravascular ultrasound (IVUS) provides a sensitive and reproducible measure of the dimensions of the vessel and allows direct visualization of the vessel wall, atherosclerotic plaque and arterial lumen. The utility of grayscale IVUS as prognostic tool and as a guide in percutaneous coronary interventions (PCI) is well established. More recently, IVUS has also provided new insights for safety and efficacy of drug eluting stent (DES).

Advances in technology now allow IVUS to characterize the morphology and composition of plaques. Specifically, the analysis of the IVUS wave frequency - beyond the interpretation of wave lengths used in grayscale IVUS- enables in vivo analysis of atherosclerotic plaque composition with high sensitivity and specificity. Although previous studies have reported data using IVUS radiofrequency analysis, the use of a new modality (iMapTM, Boston Scientific, Santa Clara, CA, USA) for characterization of atherosclerotic plaque is poorly known.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age < 75 years
  • •Diagnosis of NSTEMI/STEMI with prior use of fibrinolytics in the past 7 days
  • •Signature of the Term of Informed Consent

排除标准

  • •Hemodynamic instability
  • •Clinical signs of post-AMI ventricular dysfunction (Killip III/IV)
  • •Angiographic findings of (1)coronary anatomy with significant tortuosity, (2) critical coronary obstruction preventing the passage of the IVUS catheter and (3) total occlusion of any of the three epicardial coronary arteries.

研究组 & 干预措施

IVUS

Other

Patients undergoing catheterization due to acute coronary syndrome will have IVUS done with grayscale and iMAP analysis performed.

干预措施: iMAP (Device)

结局指标

主要结局

Atherosclerotic plaque composition

时间窗: Patients will be followed during in-hospital period, an expect average of 7 days

Atherosclerotic plaque composition of "culprit" and "non-culprit" lesions will be evaluated using grayscale IVUS and iMAP analysis in patients presenting with acute coronary syndrome.

次要结局

未报告次要终点

研究者

发起方
Federal University of São Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Cristiano Freitas de Souza

M.D.

Federal University of São Paulo

研究点 (1)

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