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临床试验/NCT02569177
NCT02569177撤回不适用

Evaluation of the Association Between Heart Type Fatty-acid Binding Proteins and High Sensitive Troponin and Postoperative Myocardial Infarction in Patients Undergoing Cardiac Surgery.

UMC Utrecht0 个研究点开始时间: 2015年11月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
UMC Utrecht
主要终点
Postoperative myocardial infarction

研究概览

简要总结

Myocardial infarction and subsequent myocardial injury after cardiac surgery occurs in 7-15% of patients undergoing cardiac surgery and is associated with an increased length of stay, and reduced short- and long-term survival. Cardiac troponin is considered to be a cornerstone in the diagnosis of a myocardial infarction. Heart-type Fatty Acid-Binding Protein (H-FABP) is a new sensitive biomarker for myocardial injury. The effectiveness of using the combination of H-FABP with Troponin to diagnose myocardial injury within 6 hours after the onset of ischemia is well reported. Previous studies in non-surgical patients have associated increased H-FABP with an increased risk of subsequent death and major cardiac events. The prognostic value in cardiac surgery patients has not been studied extensively.

The objective is to estimate the association between biomarkers of myocardial injury and myocardial infarction in patients undergoing cardiac surgery. Myocardial infarction will be established with both a new and very early marker of myocardial injury (Heart-type Fatty Acid Binding Proteins) as well as to a known early marker of such injury (Cardiac troponin).

详细描述

Specific aims:

  1. To obtain an estimate of the association between a new very early marker of postoperative myocardial injury H-FABP and postoperative myocardial infarction.
  2. To obtain an estimate of the association between cTn-I and postoperative myocardial infarction.
  3. To obtain an estimate of the correlation between H-FABP elevation and cTn-I elevation in patients undergoing cardiac surgery.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years or older
  • isolated coronary artery bypass grafting
  • isolated valve surgery
  • combined coronary artery bypass grafting and valve surgery

排除标准

  • emergency surgery patients
  • (suspected) sepsis
  • pulmonary embolism
  • renal failure (Glomerular filtration rate < 40 ml/min)
  • off pump cardiac surgery

结局指标

主要结局

Postoperative myocardial infarction

时间窗: 30 days after cardiac surgery

The occurence of postoperative myocardial infarction is imported from the Board Heart interventions Netherlands registry (BHN registry). For every patient undergoing cardiac surgery in the UMCU the cardiothoracic department determines whether the patient had a postoperative myocardial infarction or not and fills out the related information in the BHN registry.

次要结局

  • Hospital length of stay(1 year after cardiac surgery)
  • Mortality(30-days and 1-year after cardiac surgery)

研究者

发起方
UMC Utrecht
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. B. van Zaane

MD, PhD

UMC Utrecht

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