Plain English Summary
Background and study aims
Sudden cardiac arrest (SCA) is a serious medical condition in which the heart suddenly stops beating and is a major cause of death in people across all age groups. There is some evidence suggesting that an inherited predisposition for primary ventricular fibrillation (a heart rhythm abnormality), which occurs in the early stages of a heart attack, could be related to risk of death from SCA. The aim of this study is to look at the relationship between inherited factors (genetic variants) in patients having their first heart attack to with and without ventricular fibrillation.
Who can participate?
Adults aged 75 years or over who have had a heart attack with or without ventricular fibrillation.
What does the study involve?
After agreeing to take part, participants have a blood sample taken which is then frozen. In addition, information about their medical history and personal characteristics is collected using questionnaires. One year later, participants have their medical records reviewed in order to find out how many are still living. The blood samples provided at the start of the study are also tested to find out if there is a link between genes and their risk of developing ventricular fibrillation in the 24 hours following their heart attack.
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?
Fondazione IRCCS Policlinico San Matteo (Italy)
When is the study starting and how long is it expected to run for?
April 2009 to December 2020
Who is funding the study?
Università degli Studi di Pavia (Italy)
Who is the main contact?
Professor Gaetano Maria De Ferrari
g.deferrari@smatteo.pv.it
Trial website
Contact information
Type
Scientific
Primary contact
Prof Gaetano Maria De Ferrari
ORCID ID
http://orcid.org/0000-0003-4940-0876
Contact details
Unità Coronarica LSR Sperimentazione cardiologica
Fondazione IRCCS Policlinico San Matteo
Piazzale Golgi 19
Pavia
27100
Italy
+39 382 503715
g.deferrari@smatteo.pv.it
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
20130005044
Study information
Scientific title
Assessment of genetic predisposition to development of primary ventricular fibrillation in patients with acute myocardial infarction
Acronym
PREDESTINATION
Study hypothesis
The aim of this study is to identify genetic variants that could be involved in the development of ventricular fibrillation in the 24 hours following the first myocardial infarction.
Ethics approval
The Bioethics Comittee (IRB) of the Fondazione IRCCS Policlinico San Matteo, 06/04/2009, ref: P-20090008508
Amendment approved: 17/11/2013
Study design
Multi-centre case-control observational 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 contact details to request a participant information sheet
Condition
Myocardial infarction
Intervention
Following provision of informed consent, all participants have a blood sample taken which is immediately frozen for the future primary outcome analysis. Peripheral blood samples are drawn into n°3 BD Vacutainer blood tubes (containing 3,2% sodium citrate) of 3,5 ml each and immediately stored at -80°C. After a reasonable amount of patients is enrolled (around n°50), Genomic DNA is extracted using a magnetic particle-based methodology (Maxwell 16 Blood DNA purification kit, Promega), according to the manufacturer’s recommendations. All DNAs’ concentrations is determined by spectrophotometry (Nano-Drop, Celbio) and is then normalized at an appropriate concentration for downstream analyses.
Information about medical history and demographic data is also collected. Survival status 1 year after the index event will also be collected through medical record review.
Intervention type
Other
Phase
Drug names
Primary outcome measures
Genetic loci associated with ventricular fibrillation risk during myocardial infarction are assessed through analysis of 1,536 SNPs (single nucleotide polymorphisms) using the GoldenGate method (Illumina) with a custom-made chip and the Genome Wide Association Study (GWAS) technique at 1 year.
Secondary outcome measures
1. Relationship between the occurrence of ventricular fibrillation and
1.1. familiarity for sudden death
1.2. Smoking habit
1.3. Hypokalemia
1.4. Hyperkalemia
1.5. Prolonged corrected QT interval
is assessed using information collected using case reports collected at baseline
2. Survival status is assessed through medical record review at one year
Overall trial start date
06/04/2009
Overall trial end date
31/12/2020
Reason abandoned
Eligibility
Participant inclusion criteria
Cases:
1. Age between 18 and 75 years, inclusive
2. At least one episode of cardiac arrest due to ventricular fibrillation within 24 h of onset of symptoms of heart attack documented in the index electrocardiogram
Controls:
1. Age between 18 and 75 years, inclusive
2. Episode of myocardial infarction within 24 h of onset of symptoms
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
4000
Participant exclusion criteria
Case Patients Exclusion criteria:
1. Age younger than 18 or older than 75 years
2. History of previous myocardial infarction
3. Pre-existing significant cardiac disease and / or associated with Ejection Fraction less than or equal to 30%
4. Presence of arrhythmogenic diseases that affect the occurrence of major ventricular arrhythmias (TV, FV) independently by the ischemic event (arrhythmogenic right end/or left ventricular cardiomiopathies, long- and short-QT syndrome; Brugada syndrome and Cathecolaminergic polymorphic ventricular tachicardia)
Control Patients Exclusion criteria:
1. Age younger than 18 or older than 75 years
2. History of previous myocardial infarction
3. Pre-existing significant cardiac disease and / or associated with Ejection Fraction less than or equal to 30%
4. Presence of arrhythmogenic diseases that affect the occurrence of major ventricular arrhythmias (TV, FV) independently by the ischemic event (arrhythmogenic right end/or left ventricular cardiomiopathies, long- and short-QT syndrome; Brugada syndrome and Cathecolaminergic polymorphic ventricular tachicardia)
Recruitment start date
01/09/2009
Recruitment end date
01/07/2019
Locations
Countries of recruitment
Italy
Trial participating centre
Fondazione IRCCS Policlinico San Matteo
Piazzale Golgi 19
Pavia
27100
Italy
Funders
Funder type
University/education
Funder name
Università degli Studi di Pavia
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 after all samples will be analized for primary endpoint.
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
31/12/2021
Participant level data
To be made available at a later date
Results - basic reporting
Publication summary