Arrhythmia Genetics in the NEtherlandS
AGNES
1 other identifier
observational
2,000
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 21, 2016
CompletedFirst Posted
Study publicly available on registry
January 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedJanuary 10, 2017
January 1, 2017
7.9 years
December 21, 2016
January 9, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Differences in genetic and inflammatory profile between cases and controls.
Differences in genetic profile and inflammatory profile between cases and controls are investigated between the complete cohorts.
Immediately upon admission, measures are based on samples taken at admission.
Secondary Outcomes (1)
Differences in clinical characteristics between cases and controls
Immediately upon admission, measures are based on status at hospital admission.
Other Outcomes (1)
Previously described risk factors
Immediately upon admission, measures are based on status at hospital admission.
Study Arms (2)
AGNES Controls
AGNES controls are individuals with a first acute ST-elevation myocardial infarction but without ventricular fibrillation.
AGNES cases
AGNES cases have ECG- registered ventricular fibrillation occurring before reperfusion therapy for an acute and first ST-elevation myocardial infarction.
Eligibility Criteria
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.
You may qualify if:
- First ST elevation myocardial infarction (STEMI)
- Between 18 and 80 years old
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (3)
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.
PMID: 21461030BACKGROUNDBezzina 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.
PMID: 20622880RESULTGho 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.
PMID: 29296283DERIVED
Biospecimen
DNA from blood.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. dr.
Study Record Dates
First Submitted
December 21, 2016
First Posted
January 2, 2017
Study Start
February 1, 2010
Primary Completion
January 1, 2018
Last Updated
January 10, 2017
Record last verified: 2017-01