Condition category
Circulatory System
Date applied
18/11/2016
Date assigned
29/12/2016
Last edited
28/12/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Sponsor information

Organisation

Università degli Studi di Pavia

Sponsor details

Area Ricerca - Servizio Ricerca e Terza Missione
C.so Strada Nuova
65
Pavia
27100
Italy

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes