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临床试验/NCT03203057
NCT03203057已完成不适用

Serial Measurements of High-sensitivity Cardiac Troponin T and Troponin I After Short, Controlled Induced Cardiac Ischemia

Herlev Hospital1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2016年10月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
1
主要终点
Troponin release

研究概览

简要总结

Background Troponin are proteins found in the cardiomyocyte and are a cornerstone in the diagnoses of acute myocardial infarction. Troponin is released to the bloodstream as a result of an cardiomyocyte injury. Troponin is frequently assessed in hospital care for patients with chest pain and dyspnea.

Guidelines recommend troponin assessment at admission and repeated at 3 to 6 hours, depending on the assay. High-sensitivity assays measure concentrations that are ten-times lower than earlier generations of assays. However, the time from when troponin is elevated in the bloodstream after an ischemic injury, measured with high-sensitivity assays, are not fully known.

During an X-ray imaging of the heart's blood vessels (coronary angiogram) it is possible to do a short, controlled occlusion of coronary artery by inflating a small balloon in one of the coronary arteries. Numerous earlier studies in patients have used this method for induced occlusion of one coronary artery for 1 to 3 minutes. Only one of the studies measured troponin I.

The aim with this study is to quantify and compare the release of troponin T and troponin I in the early hours after a controlled induced ischemia.

Study Design This is a prospective, descriptive and experimental study. There will be included 40 patients, without acute ischemic cardiac disease. They will be randomized in 4 groups.

0: 10 patients - control group, no balloon occlusion

  1. 10 patients - balloon occlusion for 30 seconds
  2. 10 patients - balloon occlusion for 60 seconds
  3. 10 patients - balloon occlusion for 90 seconds

Subsequently there will be assessed serial blood samples 0 - 3 hours: Every 15 minutes 3 - 6 hours: Every 30 minutes

Statistics This is a pilot study and it is estimated that ten patients are sufficient number of patients in each group to assess elevation of troponin after occlusion of coronary artery. The thesis is there is a dosage-response correlation between the length of balloon occlusion and the concentration of troponin in blood stream.

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
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • > 18 years of age Elective coronary angiogram Informed signed accept

排除标准

  • Stenosis or atherosclerosis of the coronary artery Renal Failure or p-creatinin > 100 µmol/L Heart Failure or LVEF < 50 Severe Heart Valve Disease

结局指标

主要结局

Troponin release

时间窗: 6 hours

Quantifying troponin T and I release after ischemic event

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

Asthildur Arnadottir

Medical Doctor

Herlev Hospital

研究点 (1)

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