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Molecular Autopsy in Young Individuals With Sudden Cardiac Death

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Re-verified, no change to tracked fields
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this observational study is to create and test a pilot workflow for molecular autopsy (genetic testing after death) in children and adults aged 1 to 50 years who died suddenly from an unexplained cause and were examined at the Death Verification Service of the city of São Paulo, Brazil. The main questions it aims to answer are: * How often can a genetic cause of sudden death be found in young people in Brazil? * Can first-degree relatives who carry the same genetic change be identified and referred for heart screening before they have symptoms? Sudden cardiac death in young people is often caused by inherited heart diseases, such as heart rhythm disorders and diseases of the heart muscle. Death may be the first sign of the disease in a family. Most of what is known comes from studies in North America, Europe and Australia, and there are no such data for the Brazilian population. After a family member gives consent, the researchers will: * Interview the family using a verbal autopsy questionnaire and review the autopsy report and death certificate * Collect blood or tissue during the autopsy for genetic testing (whole exome sequencing) * Examine the heart under the microscope When a genetic cause is found, the results will be given to the responsible family member, and first-degree relatives (parents, siblings and children) will be invited to take part. Relatives who agree will give a small blood sample (about 10 mL) to test for the same genetic change. Relatives who carry the change will be referred for heart screening.
Trial Details
NCT Number NCT07849738
Lead Sponsor University of Sao Paulo
Conditions Tachycardia
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov