ClinicalTrials.gg
RecruitingNCT02168088Updated Jan 16, 2025

Molecular Autopsy Study

An observational study in Sudden Unexplained Death, sponsored by Scripps Translational Science Institute. Recruiting at 1 site in United States. Open to participants aged Up to 45 Years. Per ClinicalTrials.gov, last updated 2025-01-16.

Sponsored by Scripps Translational Science Institute · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 5 months ago, but the record still lists the study as recruiting.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
100
Ages
Up to 45 Years
Sex
All
01

Study summary

This study seeks to incorporate genetic testing into the postmortem examination of cases of sudden unexplained death.

Read the detailed description

This study seeks to incorporate genetic testing into the postmortem examination of cases of sudden unexplained death, initially in San Diego County with plans to expand nationally and internationally as funding allows. Genetic testing of the index subjects and their parents (or other biological family members if parents are not available) will be assessed for potential heritable causes of sudden death. By combining the wide catchment base of the San Diego Medical Examiner's Office, sequencing expertise of SD-based collaborators, computing power of the San Diego Supercomputer Center and in-house and external genomic analytics, the Scripps Translational Science Institute aims to provide a more complete characterization and understanding of the genetic causes of sudden death. Ultimately, findings from this study will be utilized to identify previously unrecognized mechanism of sudden death allowing for the development of preventative screening programs and potentially life-saving interventions.

02

Conditions studied

  • Sudden Unexplained Death

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Keywords

  • Sudden unexplained death
03

In context

Death

456 studies on the registry are indexed under Death; 86 are open to participants now.

This study's planned enrollment of 100 is below the median of 400 across 236 observational studies indexed under Death.

Browse Death studies →

Lead sponsor

Scripps Translational Science Institute is the lead sponsor of 53 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study population is limited to cases of sudden unexplained death in San Diego County and their living, biologically-related family members.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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 )
  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Index case

    Subjects who have died of sudden unexplained death

  • Biologically related family member

    Biologically related family member of the deceased individual

06

What researchers measure

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.

    Time frame: 3 years

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02168088
Lead sponsor
Scripps Translational Science Institute
Responsible party
Eric Topol, MD (PI, Director STSI, Scripps Translational Science Institute) — Principal investigator
First posted
Jun 20, 2014
Start date
Jun 2014
Primary completion
Jun 2025 (estimated)
Completion
Jun 2030 (estimated)
Last update
Jan 16, 2025

Study contacts

Sarah Topol, RN
Contact
topol.sarah@scrippshealth.org
858-784-2155
Emily Spencer, Phd
Contact
egspence@scripps.edu
858-784-2029

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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