Plain English Summary
Background and study aims
Sudden cardiac death (SCD) caused by ventricular fibrillation (VF) during a heart attack (cardiac arrest) is a leading cause of natural death worldwide. VF is a heart rhythm problem where the heart beats so rapidly and erratically, causing the chambers of the heart to quiver uselessly rather than pump blood around the body. Studies have shown that there is a genetic (inherited) component, indicating that sudden death of a family member is a risk factor for SCD and VF. Even though new insights and technology have become available, the nature of this remains poorly understood. Understanding the underlying genetic causes of SCD and VF would be a valuable means of being any to predict and prevent development of VF and develop new treatments. This study aims to evaluate the genetic components associated with VF in order to understand the underlying mechanisms.
Who can participate?
Adults having their first ST-elevations MI (STEMI – a type of heart attack) with and without VF within the first 12 hours.
What does the study involve?
Participants are recruited at the point of their STEMI. At this time, information about the participants and their medical history is collected by the researchers using questionnaires. If any information is missing, then the researchers have permission to contact the participants after they are discharged from hospital. While they are in hospital, a blood sample is collected to use for genetic analysis. After they are discharged, participants are followed up for five years to look for death of any cause by reviewing Danish nationwide registries and medical records.
What are the possible benefits and risks of participating?
There are no direct benefits or risks involved with participating.
Where is the study run from?
1. University Hospital of Copenhagen (Denmark)
2. Odense University Hospital (Denmark)
3. Aarhus University Hospital, Skejby (Denmark)
4. Aalborg University Hospital (Denmark)
When is the study starting and how long is it expected to run for?
July 2010 to July 2023
Who is funding the study?
1. The John and Birthe Meyer Foundation (Denmark)
2. The Novo Nordisk Foundation (Denmark)
Who is the main contact?
Dr Jacob Tfelt-Hansen
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
H-3-2010-133
Study information
Scientific title
GEnetic causes of Ventricular Arrhythmias in patients with first STEMI (GEVAMI) study
Acronym
GEVAMI
Study hypothesis
1. Genetic factors play a significant role in ventricular fibrillation (VF) caused by first ST-elevation myocardial infarction (STEMI)
2. VF during ischemia has a multifactorial and complex nature with a familial aggregation, implicating a genetic cause.
Ethics approval
National Committee on Health Research Ethics, 25/05/2011, protocol number: H-3-2010-133
Study design
Nationwide prospective case-control study
Primary study design
Observational
Secondary study design
Case-control study
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Ventricular fibrillation
Intervention
Participants are recruited at the point of first STEMI. Baseline demographics and previous medical history are collected by researchers by using standardized questionnaires while the participant is in hospital. If data was missing in the questionnaires, the researchers have permission to contact the patient after the discharge. In addition, medical records are collected and the comprehensive Danish nationwide registries are used to describe comorbidities and for follow up. Blood sample is collected during hospitalisation, often at the same time as participants undergo routine blood testing. This is used for future genetic analysis.
Participants are followed up continuously for 5 years by reviewing Danish registries to assess for all-cause mortality.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Common and rare genetic variants associated with ventricular fibrillation (VF) during first ST-elevation myocardial infarction (STEMI), analysed by genome-wide association studies and next generation sequencing
Secondary outcome measures
All-cause mortality is measured using the Danish registries continuously for 5 years
Overall trial start date
03/07/2010
Overall trial end date
03/07/2023
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Cases
1. First STEMI patients who experienced VF within the first 12 hours of symptoms of STEMI before PPCI
2. Age between 18 and 80 years
3. Caucasians
4. Cardiac symptoms lasting ≤12 hours
5. Acute ST-segment elevation revealed by ECG
Controls:
1. First STEMI patients who did not have VF during the first 12 hours of symptoms of STEMI before PPCI
2. Age between 18 and 80 years
3. Caucasians
4. Cardiac symptoms lasting ≤12 hours
5. Acute ST-segment elevation revealed by ECG
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1500 cases and 1500 controls
Participant exclusion criteria
1. Cases and controls who developed VF during PPCI will be excluded because VF during PPCI is believed to be reperfusion induced; however, case patients with VF before PPCI who continued to have VF during PPCI can participate
2. Other exclusions included VF after PPCI
3. Congenital heart defects
4. Known structural heart disease
5. Use of class I and III antiarrhythmic drugs
6. Recent cancer
7. Major surgery or trauma within 4 weeks
8. Presentation with potassium concentration of <3 or >5 mmol/L
9. Because we also planned to identify genetic markers associated with VF, and because >90% of the Danish populations are white Danes, we excluded non-white Danes to reduce the risk of population stratification for future genetic analysis
Recruitment start date
03/07/2011
Recruitment end date
03/07/2020
Locations
Countries of recruitment
Denmark
Trial participating centre
University Hospital of Copenhagen
The Heart Centre
Department of Cardiology
Rigshospitalet
Blegdamsvej 9
Copenhagen
2100
Denmark
Trial participating centre
Odense University Hospital
Department of Cardiology
Søndre Blvd. 29
Odense
5000
Denmark
Trial participating centre
Aarhus University Hospital, Skejby
Department of Cardiology
Palle Juul-Jensens Blvd. 99
Aarhus
8200
Denmark
Trial participating centre
Aalborg University Hospital
Department of Cardiology
Hobrovej 18-22
Aalborg
9100
Denmark
Funders
Funder type
Charity
Funder name
The John and Birthe Meyer Foundation
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Novo Nordisk Foundation
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal, around one year after your overall trial end date.
IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
03/07/2024
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list
2015 results in https://www.ncbi.nlm.nih.gov/pubmed/25559012