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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03007199
Other study ID # CCMO # 13598
Secondary ID
Status Enrolling by invitation
Phase N/A
First received December 21, 2016
Last updated January 9, 2017
Start date February 2010

Study information

Verified date January 2017
Source Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 2000
Est. completion date
Est. primary completion date January 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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).

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

References & Publications (2)

Bezzina CR, Pazoki R, Bardai A, Marsman RF, de Jong JS, Blom MT, Scicluna BP, Jukema JW, Bindraban NR, Lichtner P, Pfeufer A, Bishopric NH, Roden DM, Meitinger T, Chugh SS, Myerburg RJ, Jouven X, Kääb S, Dekker LR, Tan HL, Tanck MW, Wilde AA. Genome-wide — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Previously described risk factors 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 Immediately upon admission, measures are based on status at hospital admission. No
Primary 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. No
Secondary Differences in clinical characteristics between cases and controls Differences in clinical characteristics between cases and controls are investigated between the complete cohorts. Immediately upon admission, measures are based on status at hospital admission. No
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