Registry Using IVUS and iMAP to Evaluate Atherosclerotic Coronary Plaque in Acute Coronary Syndromes
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
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
Cristiano Freitas de Souza
M.D.
Federal University of São Paulo
