Arrhythmia Genetics in the NEtherlandS

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03007199

Acronym

AGNES

Enrollment

2000

Registered

2017-01-02

Start date

2010-02-28

Completion date

Unknown

Last updated

2017-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction First, 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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Other

Measure	Time frame	Description
Previously described risk factors	Immediately upon admission, measures are based on status at hospital admission.	Clinical characteristics that were previously described as possible risk factors for the development of VF (ventricular Fibrillation) during AMI (acute myocardial infarction): certain ECG characteristics, infarct size, infarct location, extent and localization of coronary disease. Are investigated for differences between cases and controls in the complete cohorts

Outcome results