Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03111043
Enrollment
104
Registered
2017-04-12
Start date
2015-12-01
Completion date
2021-07-01
Last updated
2024-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Out-Of-Hospital Cardiac Arrest, Sudden Death

Keywords

computed tomography, Sudden cardiac arrest, Cardiac computed tomography, Diagnostic accuracy, Clinical outcome

Brief 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.

Detailed description

Best practices for survivors of out-of-hospital sudden death are underdeveloped and untested. Early diagnosis in sudden death survivors is challenging due to patient intubation and obtundation, limited history, and imprecise standard of care testing. Sudden death without an obvious cause (termed idiopathic sudden death) is primarily caused by cardiovascular disease although a large number of cases result from non-cardiac disease. Improvements in computed tomography (CT) technologies provides a means to identify up to 86% of idiopathic causes of sudden death, including cardiovascular and coronary artery disease, cerebral disease, pulmonary embolism and abdominal catastrophe4 as well as secondary injury from cardiopulmonary resuscitation. To date, use of early CT scans on consecutive sudden death survivors has not been reported. The innovation of this pilot trial is to be first to test whether a comprehensive head-to-pelvis, ECG-gated contrast CT scan (CT-First) can identify the majority of causes for idiopathic sudden death. The significance of CT-First approach is potentially reducing diagnostic errors, treatment delays and inappropriate treatments to potentially improve clinical outcomes in this very high risk population. The expertise of the medical centers involved, combined with the highly respected Medic One service, provide an unusual opportunity to test this diagnostic paradigm with cutting edge CT technologies. The data generated from this study will be used to plan larger randomized trials of early contrast CT scanning versus invasive coronary angiography in sudden death survivors and may be extrapolated to other patient populations such as possible acute coronary syndrome or after trauma.

Interventions

DIAGNOSTIC_TESTHead to pelvis CT scan

Introduction of early head to pelvis CT scan within 6 hours of out of hospital arrest as an adjunct to standard of care (no randomization)

Sponsors

Medic One Foundation
CollaboratorOTHER
Harborview Injury Prevention and Research Center
CollaboratorOTHER
University of Washington
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Patients reaching the Emergency Department within 6 hours of resuscitated sudden death. 2. No obvious cause for sudden death event with initial standard of care clinical evaluation 3. Clinically stable to have CT performed per treating physician 4. Candidates for continued intubation and sedation during the CT scan with or without therapeutic hypothermia protocol.

Exclusion criteria

1. 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 2. Obvious cause of sudden death - Examples: witnessed trauma, drowning, suicide attempt 3. Known non-revascularized coronary artery disease or coronary stent \<2.5 mm. 4. Known severe renal dysfunction (eGFR\<30 ml/hr, creatinine \>1.7 mg/dl) 5. Implantable defibrillator, due to metal artifact from defibrillator coil 6. Known iodinated contrast allergy 7. Known hospice patient or terminal disease with expected \<3 months survival

Design outcomes

Primary

MeasureTime frame
Cost analysis of head to pelvis CT scan - payer perspectiveDuring hospitalization (up to 6 months)
Time to correct diagnosis by head to pelvis CT scanDuring hospitalization (up to 6 months)
Diagnostic accuracy compared to adjudicated diagnosis for sudden-death eventDuring hospitalization (up to 6 months)

Secondary

MeasureTime frameDescription
Determine complications of cardiopulmonary resuscitation on thoracoabdominal organs measured by CT in sudden death survivorsDuring hospitalization (up to 6 months)
Determine adjudicated causes for sudden-death event in survivorsDuring hospitalization (up to 6 months)
Clinical outcomes for sudden-death survivors undergoing head to pelvis CT scanDuring hospitalization (up to 6 months)Clinical outcomes include in-hospital survival, circulatory arrest, survival to discharge, and discharge status (discharge to home, nursing facility)

Other

MeasureTime frame
Safety outcome: Incidence of contrast associated acute kidney injury.48 hours from CT scan (up to 6 months)
Safety outcome: Prevalence of false positive CT findings leading to incorrect treatmentDuring hospitalization (up to 6 months)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026