NCT00558441Unknown不适用
Prospective Data Collection in Clinical Cases Where Coronary Plaque Lipid Characterization by IVMRI Was Performed During Diagnostic or Interventional Catheterization Procedures
TopSpin Medical1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2007年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- LFI - Lipid Fraction Index
研究概览
简要总结
The study purpose is to prospectively collect data for a set of predefined variables in clinical cases where coronary plaque lipid characterization by IVMRI was performed during diagnostic or interventional procedures in order to gather incremental information beyond angiography and other diagnostic modalities.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •An adult patient ≥ 18 years old.
- •The patient, or legal guardian, has been informed of the nature of the study, agrees to its provisions, and has sign the approved informed consent.
- •The patient and the treating physician agree to attend the follow-ups as defined in the study protocol.
- •Indication for diagnostic and/or interventional procedure.
- •Lesions in a native vessels where IVMRI interrogation may provide additional information beyond angiography and other diagnostic tools.
排除标准
- •Culprit lesions within 48 hours following STEMI.
- •Tortuous vessels, calcified or thrombotic lesions.
- •Significant stenosis of an unprotected left main coronary artery.
- •IVMRI interrogation of an unprotected left main coronary artery.
- •Patients with pacemaker or cardioverter defibrillator.
- •The patient is suffering from transplant mediated coronary artery disease.
结局指标
主要结局
LFI - Lipid Fraction Index
时间窗: 5 years
次要结局
- correlation between LFI and a set of predefined parameters(5 years)
研究者
研究点 (1)
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