Molecular Autopsy Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Sudden Unexplained Death. Basic parameters: up to 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Molecular Autopsy for Sudden Cardiovascular Death
Overview
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.
Primary outcome measures
- Heritable causes of sudden death [Time frame: 3 years]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- Scripps Translational Science Institute — La Jolla
Identifiers
NCT: NCT02168088 · 14-6386