Molecular Autopsy Study
Molecular Autopsy for Sudden Cardiovascular Death
1 other identifier
observational
100
1 country
1
Brief Summary
This study seeks to incorporate genetic testing into the postmortem examination of cases of sudden unexplained death.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 10, 2014
CompletedFirst Posted
Study publicly available on registry
June 20, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2030
ExpectedJanuary 16, 2025
January 1, 2025
11 years
June 10, 2014
January 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Heritable causes of sudden death
The primary endpoint for this study is the discovery of genomic information that may help identify a potential cause of death in the index case. This information may inform living, biologically related family members of their potential risk and need for further genomic analysis.
3 years
Study Arms (2)
Index case
Subjects who have died of sudden unexplained death
Biologically related family member
Biologically related family member of the deceased individual
Eligibility Criteria
The study population is limited to cases of sudden unexplained death in San Diego County and their living, biologically-related family members.
You may qualify if:
- Index case age between birth - 45 years
- Clinical presentation of sudden / unexplained death (believed to be cardiac in nature OR secondary to a massive unprovoked pulmonary embolism with no prior diagnosis of prothrombotic disease)
You may not qualify if:
- Premature death secondary to murder, suicide or external causal event
- Premature death thought secondary to known chronic comorbid medical condition
- Premature death thought secondary to end-organ failure (kidney, liver, lung) other than heart
- Previously diagnosed with hypertrophic cardiomyopathy (HCM)
- Prior myocardial infarction (regardless of stenting or bypass)
- Prior cerebrovascular accident (stroke or TIA)
- History of open heart surgery (for any reason)
- History of severe, untreated hypertensive heart disease
- History of illicit drug use
- History of heavy alcohol abuse
- History of severe pulmonary disease
- History of morbid obesity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Scripps Translational Science Institute
La Jolla, California, 92037, United States
Biospecimen
Blood and/or tissue will be collected on the deceased individual. Saliva samples will be collected on family members who have consented to participate.
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PI, Director STSI
Study Record Dates
First Submitted
June 10, 2014
First Posted
June 20, 2014
Study Start
June 1, 2014
Primary Completion
June 1, 2025
Study Completion (Estimated)
June 1, 2030
Last Updated
January 16, 2025
Record last verified: 2025-01