Condition category
Circulatory System
Date applied
03/11/2016
Date assigned
02/12/2016
Last edited
25/09/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Jacob Tfelt-Hansen

ORCID ID

Contact details

The Heart Centre
Department of Cardiology
University Hospital of Copenhagen
Rigshospitalet
Blegdamsvej 9
Copenhagen
2100
Denmark

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 measures

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

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

Sponsor information

Organisation

University Hospital of Copenhagen

Sponsor details

The Heart Centre
Rigshospitalet
Blegdamsvej 9
Copenhagen
2100
Denmark

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

2015 results in https://www.ncbi.nlm.nih.gov/pubmed/25559012

Publication citations

Additional files

Editorial Notes

22/09/2017: Internal review. 09/02/2017: Internal review.