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临床试验/NCT02422316
NCT02422316已完成不适用

Non-contrast Cardiac CT as a Risk Stratification Tool in Patients With Non-cardiac Chest Pain

University of Southern Denmark1 个研究点 分布在 1 个国家目标入组 248 人开始时间: 2014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
248
试验地点
1
主要终点
major cardiac events

研究概览

简要总结

Background:

Only around 20% of all patients seen in hospital with suspected Acute Coronary Syndrome will have Acute Myocardial Infarction. However, several studies indicate that patients where ACS had been excluded by conventional methods sustain a higher cardiac morbidity and mortality than the background population. Not all of these patients can be identified by traditional risk factors such as cholesterol, hypertension, and diabetes or with conventional methods such as ECG, troponin and clinical symptoms. Non-Contrast Cardiac-CT measures the amount of calcification in the coronary arteries and might be a useful addition in predicting future cardiac events in this patient group. The aim of this study is through a double-blinded study to determine whether non-contrast CT scan with calcium score can be used to identify patients at increased risk of death and cardiac event within the following 12 months after an acute admission where troponin measurements were normal.

Methods:

The study will investigate patients with suspected Acute Coronary syndrome who have been examined and subsequently sent home from an emergency- or cardiology department without ACS or another obvious explanation. 750 patients, age 30-70 years who are included in the study: "Identification of risk factors in non-cardiac chest pain patients" will be offered a non-contrast CT scan with calcium score within 14 days after the hospital contact. The participants will be included in a 12 months follow up, where the result of the calcium score is not revealed neither for the patient nor the investigator. After 12 months the results of the scan is compared with the rate of cardiac events. This project is a multicenter study and recruits patients from 6 emergency - and cardiology departments in the region of Southern Denmark.

The study commences at September 2014 and results of this project are expected to contribute to the risk stratification of Non-cardiac chest pain patients.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • chest pain with normal cardiac enzymes.
  • legal competent
  • age 30-70 years

排除标准

  • chest pain of obvious reason
  • previous acute coronary syndrome
  • previous coronary artery investigations within last five years
  • patients referred for other cardiac examinations after the current admission

结局指标

主要结局

major cardiac events

时间窗: one year

major cardiac events: cardiac deaths, revascularization, ischaemic related arrythmias, cardiac related readmissions

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christian Backer Mogensen

associate professor

University of Southern Denmark

研究点 (1)

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