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临床试验/NCT00146887
NCT00146887Unknown不适用

A Trial Comparing the Sensitivity and Specificity of Coronary Angiography With Coronary CT Angiography

Hadassah Medical Organization1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2005年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
CT sensitivity and specificity

研究概览

简要总结

The purpose of the trial is to investigate the accuracy of coronary CT compared to the conventional "gold standard" cardiac catheterization.

详细描述

40 Patients who are scheduled to undergo coronary angiogram will be recruited at Mount Scopus and Ein Kerem. Patients will be excluded if they have one or more of the following conditions

  1. CABG or stent implantation in the past.

  2. Atrial fibrillation

  3. Contraindication for beta blockers

  4. Obstructive pulmonary disease

  5. Severe peripheral vascular disease

  6. Sick sinus syndrome or AV block greater than 1st degree.

  7. Systolic blood pressure below 100 mm Hg.

  8. Renal disease or other conditions that might increase the risk of contrast nephropathy (diabetes mellitus, SLE, paraproteinemia, malignancy, liver disease)

  9. Allergy to contrast material.

Coronary CT angiography: Patient preparation and data acquisition Pre-procedure preparation: Following informed consent, patients will be scheduled to undergo coronary CT angiography within 7 days prior to coronary angiogram. Patients with heart rates above 75 BPM's will be given 25 mg of metoprolol P.O. 60-90 minutes before the test. If the patient does not reach heart rate below 75, administration of additional IV metoprolol may be considered by a cardiologist.

Scanning protocol: Images will be obtained using collimation of 16x0.75 mm, slice thickness 1 mm reconstructed at increments of 0.5 mm, rotation time 0.42 seconds, kVp 140 and mAs 400. Prior to scanning, 120-150cc of non-ionic contrast material will be injected to a peripheral vein at a rate of 4-5mm/sec. Images will be obtained with ECG gating.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
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

  • 40 Patients who are scheduled to undergo coronary angiogram will be recruited at Mount Scopus and Ein Kerem

排除标准

  • CABG or stent implantation in the past.
  • Atrial fibrillation
  • Contraindication for beta blockers
  • Obstructive pulmonary disease
  • Severe peripheral vascular disease
  • Sick sinus syndrome or AV block greater than 1st degree.
  • Systolic blood pressure below 100 mm Hg.
  • Renal disease or other conditions that might increase the risk of contrast nephropathy (diabetes mellitus, SLE, paraproteinemia, malignancy, liver disease)
  • Allergy to contrast material.

结局指标

主要结局

CT sensitivity and specificity

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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