CompletedNot Applicable

Head-to-pelvis Computed Tomography Evaluation of Sudden Death Survivors

United States104 participantsStarted 2015-12-01

Plain-language summary

Out-of-hospital arrest can occur from multiple etiologies. In patients without an obvious reason for the sudden-death event, diagnostic evaluation is not clear. This study is to determine if early imaging with a head-to-pelvis CT scan may improve diagnostic accuracy, speed of diagnosis and potentially clinical outcomes.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patients reaching the Emergency Department within 6 hours of resuscitated sudden death.
✓. No obvious cause for sudden death event with initial standard of care clinical evaluation
✓. Clinically stable to have CT performed per treating physician
✓. Candidates for continued intubation and sedation during the CT scan with or without therapeutic hypothermia protocol.

Exclusion criteria

✕. Meets criteria for acute ST elevation myocardial infarction (ST elevation ≥1 contiguous lead or new or unknown duration left bundle branch block on ECG) or has other indication for ICA
✕. Obvious cause of sudden death - Examples: witnessed trauma, drowning, suicide attempt
✕. Known non-revascularized coronary artery disease or coronary stent \<2.5 mm.
✕. Known severe renal dysfunction (eGFR\<30 ml/hr, creatinine \>1.7 mg/dl)
✕. Implantable defibrillator, due to metal artifact from defibrillator coil
✕. Known iodinated contrast allergy
✕. Known hospice patient or terminal disease with expected \<3 months survival

What they're measuring

Diagnostic accuracy compared to adjudicated diagnosis for sudden-death event

Timeframe: During hospitalization (up to 6 months)

Time to correct diagnosis by head to pelvis CT scan

Timeframe: During hospitalization (up to 6 months)

Cost analysis of head to pelvis CT scan - payer perspective

Timeframe: During hospitalization (up to 6 months)

Trial details

NCT IDNCT03111043

SponsorUniversity of Washington

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2018-02-15

View on ClinicalTrials.gov More Sudden Death trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patients reaching the Emergency Department within 6 hours of resuscitated sudden death.
✓. No obvious cause for sudden death event with initial standard of care clinical evaluation
✓. Clinically stable to have CT performed per treating physician
✓. Candidates for continued intubation and sedation during the CT scan with or without therapeutic hypothermia protocol.

Exclusion criteria

✕. Meets criteria for acute ST elevation myocardial infarction (ST elevation ≥1 contiguous lead or new or unknown duration left bundle branch block on ECG) or has other indication for ICA
✕. Obvious cause of sudden death - Examples: witnessed trauma, drowning, suicide attempt
✕. Known non-revascularized coronary artery disease or coronary stent \<2.5 mm.
✕. Known severe renal dysfunction (eGFR\<30 ml/hr, creatinine \>1.7 mg/dl)
✕. Implantable defibrillator, due to metal artifact from defibrillator coil
✕. Known iodinated contrast allergy
✕. Known hospice patient or terminal disease with expected \<3 months survival

What they're measuring

Diagnostic accuracy compared to adjudicated diagnosis for sudden-death event

Timeframe: During hospitalization (up to 6 months)

Time to correct diagnosis by head to pelvis CT scan

Timeframe: During hospitalization (up to 6 months)

Cost analysis of head to pelvis CT scan - payer perspective

Timeframe: During hospitalization (up to 6 months)