Sudden Unexplained DeathNCT02168088
Molecular Autopsy Study
An observational study of Sudden Unexplained Death, run by Scripps Translational Science Institute at 1 site in United States.
Trial summary
This study seeks to incorporate genetic testing into the postmortem examination of cases of sudden unexplained death. Read more about this study
- Who is it for?
- Ages Up to 45 years
- Conditions the study is for
- Sudden Unexplained Death
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Jun 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study population is limited to cases of sudden unexplained death in San Diego County and their living, biologically-related family members.
Who may be able to join
- 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)
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Scripps Translational Science Institute
La Jolla, California, 92037
Sarah Topol, RN, topol.sarah@scrippshealth.org
Emily Spencer, PhD, spencer.emily@scrippshealth.org
About this study
Official title: Molecular Autopsy for Sudden Cardiovascular Death
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.
- Conditions
- Sudden Unexplained Death
- Keywords
- Sudden unexplained death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Index case | Subjects who have died of sudden unexplained death | |
| Biologically related family member | Biologically related family member of the deceased individual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2025 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden Unexplained DeathStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scripps Translational Science Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Topol, MD, Scripps Translational Science Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02168088
- Sponsor's protocol ID
- 14-6386
- Status last verified
- Jan 2025
- First submitted
- 10 Jun 2014
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Autopsy for Sudden Cardiovascular Death
- ClinicalTrials.gov ID
- NCT02168088
- Acronym / sponsor ID
- 14-6386
- Conditions
- Sudden Unexplained Death
- Keywords
- Sudden unexplained death
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Scripps Translational Science InstituteUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 20 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to incorporate genetic testing into the postmortem examination of cases of sudden unexplained death.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Index case | – | –Subjects who have died of sudden unexplained death |
| Biologically related family member | – | –Biologically related family member of the deceased individual |
Who may qualify
- Ages
- Up to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study population is limited to cases of sudden unexplained death in San Diego County and their living, biologically-related family members.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sudden Unexplained Death, run by Scripps Translational Science Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Topol, RN (858-784-2155, topol.sarah@scrippshealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heritable causes of sudden death (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2025.