Molecular Autopsy Study

Sudden Unexplained Death Clinical Trial

Official title:

Molecular Autopsy for Sudden Cardiovascular Death

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02168088
• Other study ID #: 14-6386
• Status: Recruiting
• Start date: June 2014
• Est. completion date: June 2030

Study information

• Verified date: March 2021
• Source: Scripps Translational Science Institute
• Contact: Sarah Topol, RN
• Phone: 858-784-2155
• Email: topol.sarah[@]scrippshealth.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2030
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Death
• Sudden Unexplained Death

Locations

Country	Name	City	State
United States	Scripps Translational Science Institute	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
Scripps Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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