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

Completed

• Conditions: Out-Of-Hospital Cardiac Arrest; Sudden Death

• Registration Number: NCT03111043
• Lead Sponsor: University of Washington

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.

Study Timeline

• Study Start: 2015-12-01
• Study First Submitted: 2017-03-24
• Study First Submitted QC: 2017-04-05
• Study First Posted: 2017-04-12
• Primary Completion: 2018-02-15
• Study Completion: 2021-07-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy compared to adjudicated diagnosis for sudden-death event	During hospitalization (up to 6 months)
Time to correct diagnosis by head to pelvis CT scan	During hospitalization (up to 6 months)
Cost analysis of head to pelvis CT scan - payer perspective	During hospitalization (up to 6 months)

Secondary Outcome Measures

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

Trial Locations

Locations (2)

University of Washington; 🇺🇸 Seattle, Washington, United States

Harborview Medical Center; 🇺🇸 Seattle, Washington, United States