跳至主要内容
临床试验/NCT00709709
NCT00709709已完成不适用

Medical and Economic Medical Evaluation of Scan Multislice of Coronary Artery in Exploration of Stable Coronary Syndrome. Comparison With Quantitative Coronarography

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2006年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,500
试验地点
2
主要终点
Specificity and sensibility of scanner

研究概览

简要总结

Many recent publications have reported encouraging results on diagnostic cardiac multislice CT performance in 1) coronary artery disease, 2) coronary arterial bypass graft potency and 3) intrastent restenosis.

These single center studies were made on a limited number of patients (range, 50-130) and focused mainly on one of the indications mentioned above.

Moreover, results were often given after exclusion of low quality examinations. At last, no study has compared the diagnostic performance of the different CT systems '16, 40 and 64) in these populations.

详细描述

These single center studies were made on a limited number of patients (range, 50-130) and focused mainly on one of the indications mentioned above.

Moreover, results were often given after exclusion of low quality examinations. At last, no study has compared the diagnostic performance of the different CT systems '16, 40 and 64) in these populations.

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

入选标准

  • Patients' ≥18 years, of both sexes
  • Coronary angiography in patients with suspected of known CAD, instable clinical conditions.
  • Clinical status allowing performance of coronary angiography 48 à 72h after CT examination
  • Informed consent signed by patient

排除标准

  • Patients in whom clinical status does not allow delayed coronary angiography
  • Irregular heart rate, in particular atrial fibrillation
  • Renal insufficiency (serum creatinine >150 µmol/l
  • Radiology examination with use of iodin agent with 48h before) CT coronary
  • K now intolerance to iodin agents
  • Patients unable to hold breathing < 20 seconds
  • Pregnancy

研究组 & 干预措施

1

Experimental

Scan

干预措施: multislice coronary scan (Procedure)

结局指标

主要结局

Specificity and sensibility of scanner

时间窗: visit 1

次要结局

  • Quality of coronary scanner imaging(visit 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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