AGNES: Arrhythmia Genetics in the NEtherlandS

Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Other)
Overall Status
Unknown status
CT.gov ID
NCT03007199
Collaborator
(none)
2,000

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    2000 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Arrhythmia Genetics in the NEtherlandS
    Study Start Date :
    Feb 1, 2010
    Anticipated Primary Completion Date :
    Jan 1, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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 Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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).

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

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

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Connie Bezzina, Prof. dr., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
    ClinicalTrials.gov Identifier:
    NCT03007199
    Other Study ID Numbers:
    • CCMO # 13598
    First Posted:
    Jan 2, 2017
    Last Update Posted:
    Jan 10, 2017
    Last Verified:
    Jan 1, 2017

    Study Results

    No Results Posted as of Jan 10, 2017