Arrhythmia Genetics in the NEtherlandS

Ventricular Fibrillation Clinical Trial

— AGNES  

Official title:

Arrhythmia Genetics in the NEtherlandS

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03007199
• Other study ID #: CCMO # 13598
• 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. 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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Myocardial Infarction First
• Ventricular Fibrillation

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