Clinical trial NCT03007199: Arrhythmia Genetics in the NEtherlandS
Official title: Arrhythmia Genetics in the NEtherlandS
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myocardial Infarction First
Ventricular Fibrillation
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2017-01-02
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cases are patients with a first ST-elevation myocardial infarction (STEMI) referred for primary percutaneous intervention (PCI), who develop ventricular fibrillation between the onset of acute myocardial infarction (chest pain, ECG changes) and reperfusion. Reperfusion can either be spontaneous or by PCI.

Control patients are patients with a first STEMI, referred for PCI who do not develop ventricular fibrillation.

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Differences in genetic and inflammatory profile between cases and controls.
timeFrame: Immediately upon admission, measures are based on samples taken at admission.
Secondary outcomes:
measure: Differences in clinical characteristics between cases and controls
timeFrame: Immediately upon admission, measures are based on status at hospital admission.
Other outcomes:
measure: Previously described risk factors
timeFrame: Immediately upon admission, measures are based on status at hospital admission.
Locations:
Study officials:
References:
citation: Marsman RF, Wilde AA, Bezzina CR. Genetic predisposition for sudden cardiac death in myocardial ischaemia: the Arrhythmia Genetics in the NEtherlandS study. Neth Heart J. 2011 Feb;19(2):96-100. doi: 10.1007/s12471-010-0070-4. Epub 2011 Jan 28.
citation: Bezzina CR, Pazoki R, Bardai A, Marsman RF, de Jong JSSG, Blom MT, Scicluna BP, Jukema JW, Bindraban NR, Lichtner P, Pfeufer A, Bishopric NH, Roden DM, Meitinger T, Chugh SS, Myerburg RJ, Jouven X, Kaab S, Dekker LRC, Tan HL, Tanck MWT, Wilde AAM. Genome-wide association study identifies a susceptibility locus at 21q21 for ventricular fibrillation in acute myocardial infarction. Nat Genet. 2010 Aug;42(8):688-691. doi: 10.1038/ng.623. Epub 2010 Jul 11.
citation: Gho JMIH, Postema PG, Conijn M, Bruinsma N, de Jong JSSG, Bezzina CR, Wilde AAM, Asselbergs FW. Heart failure following STEMI: a contemporary cohort study of incidence and prognostic factors. Open Heart. 2017 Dec 22;4(2):e000551. doi: 10.1136/openhrt-2016-000551. eCollection 2017.