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Molecular Autopsy Study

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ClinicalTrials.gov Identifier: NCT02168088
Recruitment Status : Recruiting
First Posted : June 20, 2014
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Eric Topol, MD, Scripps Translational Science Institute

Study Description
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Brief Summary:
This study seeks to incorporate genetic testing into the postmortem examination of cases of sudden unexplained death.

Condition or disease
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
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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 2020
Estimated Study Completion Date : June 2020
Groups and Cohorts
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Group/Cohort
Index case
Subjects who have died of sudden unexplained death
Biologically related family member
Biologically related family member of the deceased individual


Outcome Measures
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Primary Outcome Measures :
  1. 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
Blood and/or tissue will be collected on the deceased individual. Saliva samples will be collected on family members who have consented to participate.

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

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
Contacts and Locations
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Information from the National Library of Medicine

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


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

Locations
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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   
Sponsors and Collaborators
Scripps Translational Science Institute
More Information
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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: April 4, 2019
Last Verified: April 2019
Keywords provided by Eric Topol, MD, Scripps Translational Science Institute:
Sudden unexplained death
Additional relevant MeSH terms:
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Death
Pathologic Processes