Arrhythmia Genetics in the NEtherlandS

• Conditions: Ventricular Fibrillation; Myocardial Infarction First

• Registration Number: NCT03007199
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2016-12-21
• Study First Submitted QC: 2016-12-29
• Status Verified: 2017-01
• Study First Posted: 2017-01-02
• Last Update Submitted: 2017-01-09
• Last Update Posted: 2017-01-10
• Primary Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

1. First ST elevation myocardial infarction (STEMI)
2. Between 18 and 80 years old

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Differences in genetic and inflammatory profile between cases and controls.	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.

Secondary Outcome Measures

Name	Time	Method
Differences in clinical characteristics between cases and controls	Immediately upon admission, measures are based on status at hospital admission.	Differences in clinical characteristics between cases and controls are investigated between the complete cohorts.