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临床试验/NCT01190579
NCT01190579Unknown不适用

Multicenter Evaluation of Coronary Dual Source CT Angiography in Patients With Intermediate Risk of Coronary Artery Stenoses

University of Erlangen-Nürnberg Medical School8 个研究点 分布在 5 个国家目标入组 398 人开始时间: 2009年8月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
398
试验地点
8
主要终点
Accuracy for the detection of coronary artery stenoses

研究概览

简要总结

The trial will investigate the accuracy of Dual Source CT coronary angiography to detect coronary artery stenoses in patients with chest pain who have, based on clinical criteria, an intermediate likelihood for the presence of coronary artery stenoses. No beta blockers will be used to lower the heart rate for the examination. The hypothesis is that Dual Source CT will allow the detection of vessels with at least one coronary artery stenosis with a sensitivity of more than 90%.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
30 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • suspected coronary artery disease
  • chest Pain
  • intermediate likelihood of coronary stenoses
  • planned invasive coronary angiography
  • age 30 to 80 years

排除标准

  • non sinus rhythm
  • contrast allergy
  • renal failure
  • unstable clinical condition
  • previous coronary revascularization
  • calcium score exceeding 800
  • inability to perform 10 second breathhold
  • possible pregnancy
  • metformin medication that cannot be interrupted
  • inability to establish antecubital iv access

结局指标

主要结局

Accuracy for the detection of coronary artery stenoses

时间窗: 72 hours

Invasive coronary angiography will be preformed within 72 hours to verify coronary CT angiography results.

次要结局

  • Safety of Ultravist 370 and Ultravist 300 for coronary CT angiography(1 hour)

研究者

发起方
University of Erlangen-Nürnberg Medical School
申办方类型
Other

研究点 (8)

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