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临床试验/NCT01604655
NCT01604655已完成不适用

ProspEctive Randomized First Evaluation in Chest Pain Trial

St. Luke's-Roosevelt Hospital Center1 个研究点 分布在 1 个国家目标入组 411 人开始时间: 2011年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
411
试验地点
1
主要终点
Change in medical regimen

研究概览

简要总结

The purpose of this study is to determine the best initial test in patients admitted to the hospital complaining of chest pain.

详细描述

Currently, physicians can either choose a stress test or a CT scan of the heart to evaluate patients admitted with with chest pain. Very little is known about which test provides the best information to physicians, positively impacts patients medical care, and decreases future hospital admissions and testing. To study this the investigators are randomizing patients admitted to our hospital with chest pain to a stress test or coronary CT angiography. The investigators will then follow these patients for a 2 year period.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • Patients with chest pain or SOB admitted for rule out acute coronary syndrome
  • Age ≥45 years
  • EKG non-diagnostic for acute coronary syndrome
  • At least 1 set of negative troponin I

排除标准

  • Patient with ST elevation myocardial infarction.
  • Patients with non-ST elevation myocardial infarction.
  • Patients with known CAD.
  • Patients with serum creatinine > 1.
  • Atrial fibrillation or marked irregular heart rhythm.
  • Patients in whom heart rate cannot be controlled.
  • Patient with allergies to iodinated contrast agents.
  • Pregnant women
  • Patients unable to give informed consent

结局指标

主要结局

Change in medical regimen

时间窗: Initial hospitalization

Downstream cardiovascular testing and hospitalization

时间窗: 2 years

Time to discharge

时间窗: Initial hospitalization

次要结局

  • Cardiovascular mortality(7 days, 30 days, 6, 12, and 24 months.)
  • Non-fatal myocardial infarction(7 days, 30 days, 6, 12, and 24 months.)
  • All-cause mortality(7 days, 30 days, 6, 12, and 24 months.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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ProspEctive First Evaluation in Chest Pain Trial | 临床试验