Arrhythmia Genetics in the NEtherlandS

NCT ID: NCT03007199

Last Updated: 2017-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Brief Summary

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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

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Conditions

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Myocardial Infarction First Ventricular Fibrillation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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AGNES Controls

AGNES controls are individuals with a first acute ST-elevation myocardial infarction but without ventricular fibrillation.

No interventions assigned to this group

AGNES cases

AGNES cases have ECG- registered ventricular fibrillation occurring before reperfusion therapy for an acute and first ST-elevation myocardial infarction.

No interventions assigned to this group

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Connie Bezzina

Prof. dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type BACKGROUND
PMID: 21461030 (View on PubMed)

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.

Reference Type RESULT
PMID: 20622880 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29296283 (View on PubMed)

Other Identifiers

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CCMO # 13598

Identifier Type: -

Identifier Source: org_study_id

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