跳至主要内容
临床试验/NCT03007199
NCT03007199Unknown不适用

Arrhythmia Genetics in the NEtherlandS

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)0 个研究点目标入组 2,000 人开始时间: 2010年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
2,000
主要终点
Differences in genetic and inflammatory profile between cases and controls.

研究概览

简要总结

The AGNES case-control set consists of individuals with a first acute ST-elevation myocardial infarction. AGNES cases have ECG- registered ventricular fibrillation occurring before reperfusion therapy for an acute and first ST-elevation myocardial infarction. AGNES controls are individuals with a first acute ST-elevation myocardial infarction but without ventricular fibrillation. All cases and controls are recruited at seven heart centers in The Netherlands. The investigators' exclude individuals with an actual non-ST-elevation myocardial infarction, prior myocardial infarction, congenital heart defects, known structural heart disease, severe comorbidity, electrolyte disturbances, trauma at presentation, recent surgery, previous coronary artery bypass graft or use of class I and III antiarrhythmic drugs. Individuals who develop ventricular fibrillation during or after percutaneous coronary intervention are not eligible. Furthermore, because early reperfusion limits the opportunity of developing ventricular fibrillation, potential control subjects undergoing percutaneous coronary intervention within 2 h after onset of myocardial ischemia symptoms were not included. This time interval is based on the observation that >90% of cases develop ventricular fibrillation within 2 h after onset of the complaint of symptoms.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • First ST elevation myocardial infarction (STEMI)
  • Between 18 and 80 years old

排除标准

  • A grandparent from non-European descent
  • Inborn errors; congenital heart defects.
  • Prior myocardial infarction (either STEMI or non-STEMI)
  • Previous CABG (coronary artery bypass graft)
  • Use of anti-arrhythmic drugs with the exception of beta-blockers, Ca2+-antagonists and lanoxin.
  • Severe current co morbidity (electrolyte disturbances, K+>5.5, K+<3.0 mmol/L, anaemia, trauma, surgery).

结局指标

主要结局

Differences in genetic and inflammatory profile between cases and controls.

时间窗: Immediately upon admission, measures are based on samples taken at admission.

Differences in genetic profile and inflammatory profile between cases and controls are investigated between the complete cohorts.

次要结局

  • Differences in clinical characteristics between cases and controls(Immediately upon admission, measures are based on status at hospital admission.)

研究者

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

Connie Bezzina

Prof. dr.

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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