Recruiting

Genetic Testing

Sponsor:

Scripps Translational Science Institute

Code:

NCT02168088

Conditions

Sudden Unexplained Death

Eligibility Criteria

Sex: All

Age: 0 - 45

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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

Conditions

Sudden Unexplained Death

Study ID

NCT02168088

Start date

Jun, 2014

Status verified date

Jan, 2025

Completion date

Jun, 2030

Anticipated

Primary completion date

Jun, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 45

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Index case

Subjects who have died of sudden unexplained death

Biologically related family member

Biologically related family member of the deceased individual

Primary outcome measure

  • Heritable causes of sudden death [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Sarah Topol, RN

858-784-2155topol.sarah@scrippshealth.org

Emily Spencer, Phd

858-784-2029egspence@scripps.edu

Locations

Scripps Translational Science Institute

Recruiting

La Jolla, California, United States, 92037

Contacts

Sarah Topol, RN

topol.sarah@scrippshealth.org

Emily Spencer, PhD

spencer.emily@scrippshealth.org

More Information

Sponsor

Scripps Translational Science Institute

Last update posted

Jan 16, 2025

Last verified

Jan, 2025

Keywords

  • Sudden unexplained death

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Scripps Translational Science Institute on 2025-01-16.