Evaluation of Genetic-molecular Causes of Out-of-Hospital Cardiac Arrest: From Patients to Families (NCT06844851) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of Genetic-molecular Causes of Out-of-Hospital Cardiac Arrest: From Patients to Families
Italy1,725 participantsStarted 2021-09-09
Plain-language summary
The aims are to define the exact prevalence of hereditary heart diseases in out-of-hospital cardiac arrest (OHCA) patients taking also into account gender, patient and OHCA characteristics, provincial settings and environmental pollution; to stratify the individualized arrhythmic risk of proband's family members to prevent further sudden cardiac deaths; to refine the classification of the variants of uncertain significance (VUS) on genes which can have the capability to drive to molecular alterations leading to arrhythmogenic hereditary heart diseases. A blood sample will be obtained during resuscitation from all the patients aged ≤50 years suffering an OHCA in Lombardy Region and then analysed for genetic variants possibly causative of cardiac diseases. Genetic data will be merged with patient, OHCA and post-resuscitation data thanks to the connection with LombardiaCARe, whilst pollution data will be retrieved from ARPA Lombardia for free. A genetic counselling and clinical-instrumental evaluation of the proband's first-degree family members will be performed if a pathogenic/likely pathogenic variant or a VUS will be disclosed during the genetic analysis.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* All the patients suffering from OHCA of medical etiology in Lombardy Region ≤50 years, for whom resuscitation manoeuvres was started by EMS (AREU)
Exclusion Criteria:
* Patients under 18 years old
* Patients with a non-medical cause of the cardiac arrest
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is looking for genetic causes of out-of-hospital cardiac arrest — if I joined, what would the genetic testing actually involve, and would my results be shared with me or my family?
2Since this trial is focused on finding the prevalence of genetic variants rather than testing a new treatment, could participating help identify whether my cardiac arrest had an inherited cause that might affect my relatives?
3This study is in a recruiting phase with no assigned treatment phase — does that mean there's no change to my current care plan if I participate, and how would it fit alongside my existing treatment?
4If a pathogenic genetic variant is found through this study, what happens next — would my doctor be involved in deciding whether my family members should also be tested?
5Are there any alternatives to joining this trial if I want to understand whether my cardiac arrest might have a genetic cause, such as standard clinical genetic testing my care team could arrange independently?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Prevalence of pathogenic/likely-pathogenic variants
Timeframe: December 2027
Trial details
NCT IDNCT06844851
SponsorFondazione IRCCS Policlinico San Matteo di Pavia