Arrhythmia Genetics in the NEtherlandS (AGNES)

January 9, 2017 updated by: Connie Bezzina, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Actual)

2000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Cases are patients with a first ST-elevation myocardial infarction (STEMI) referred for primary percutaneous intervention (PCI), who develop ventricular fibrillation between the onset of acute myocardial infarction (chest pain, ECG changes) and reperfusion. Reperfusion can either be spontaneous or by PCI.

Control patients are patients with a first STEMI, referred for PCI who do not develop ventricular fibrillation.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in genetic and inflammatory profile between cases and controls.
Time Frame: 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.
Immediately upon admission, measures are based on samples taken at admission.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in clinical characteristics between cases and controls
Time Frame: 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.
Immediately upon admission, measures are based on status at hospital admission.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Previously described risk factors
Time Frame: 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
Immediately upon admission, measures are based on status at hospital admission.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

December 21, 2016

First Submitted That Met QC Criteria

December 29, 2016

First Posted (Estimate)

January 2, 2017

Study Record Updates

Last Update Posted (Estimate)

January 10, 2017

Last Update Submitted That Met QC Criteria

January 9, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCMO # 13598

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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