Molecular Autopsy Study
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ClinicalTrials.gov Identifier: NCT02168088 |
Recruitment Status :
Recruiting
First Posted : June 20, 2014
Last Update Posted : March 17, 2021
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Condition or disease |
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Sudden Unexplained Death |
Study Type : | Observational |
Estimated Enrollment : | 100 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Official Title: | Molecular Autopsy for Sudden Cardiovascular Death |
Study Start Date : | June 2014 |
Estimated Primary Completion Date : | June 2025 |
Estimated Study Completion Date : | June 2030 |

Group/Cohort |
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Index case
Subjects who have died of sudden unexplained death
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Biologically related family member
Biologically related family member of the deceased individual
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- Heritable causes of sudden death [ Time Frame: 3 years ]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.
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | up to 45 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02168088
Contact: Sarah Topol, RN | 858-784-2155 | topol.sarah@scrippshealth.org | |
Contact: Emily Spencer, Phd | 858-784-2029 | egspence@scripps.edu |
United States, California | |
Scripps Translational Science Institute | Recruiting |
La Jolla, California, United States, 92037 | |
Contact: Sarah Topol, RN topol.sarah@scrippshealth.org | |
Contact: Emily Spencer, PhD spencer.emily@scrippshealth.org |
Responsible Party: | Eric Topol, MD, PI, Director STSI, Scripps Translational Science Institute |
ClinicalTrials.gov Identifier: | NCT02168088 |
Other Study ID Numbers: |
14-6386 |
First Posted: | June 20, 2014 Key Record Dates |
Last Update Posted: | March 17, 2021 |
Last Verified: | March 2021 |
Sudden unexplained death |
Death Pathologic Processes |