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Trial record 29 of 132 for:    "Paroxysmal Ventricular Fibrillation"

Arrhythmia Genetics in the NEtherlandS (AGNES)

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ClinicalTrials.gov Identifier: NCT03007199
Recruitment Status : Unknown
Verified January 2017 by Connie Bezzina, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
Recruitment status was:  Enrolling by invitation
First Posted : January 2, 2017
Last Update Posted : January 10, 2017
Sponsor:
Information provided by (Responsible Party):
Connie Bezzina, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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
Myocardial Infarction First Ventricular Fibrillation

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Study Type : Observational [Patient Registry]
Actual Enrollment : 2000 participants
Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Arrhythmia Genetics in the NEtherlandS
Study Start Date : February 2010
Estimated Primary Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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


Biospecimen Retention:   Samples With DNA
DNA from blood.


Information from the National Library of Medicine

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

Criteria

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).

Additional Information:

Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Connie Bezzina, Prof. dr., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT03007199     History of Changes
Other Study ID Numbers: CCMO # 13598
First Posted: January 2, 2017    Key Record Dates
Last Update Posted: January 10, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
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Ventricular Fibrillation
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arrhythmias, Cardiac