Skip to main content
OpenTrials
Completed

NCT Number: NCT03111043

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Harborview Medical Center, Seattle, Washington, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Head to pelvis CT scan

Diagnostic Test

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)

Primary outcomes

  1. Diagnostic accuracy compared to adjudicated diagnosis for sudden-death event

    Time frame: During hospitalization (up to 6 months)

  2. Time to correct diagnosis by head to pelvis CT scan

    Time frame: During hospitalization (up to 6 months)

  3. Cost analysis of head to pelvis CT scan - payer perspective

    Time frame: During hospitalization (up to 6 months)

Secondary outcomes

  1. Determine adjudicated causes for sudden-death event in survivors

    Time frame: During hospitalization (up to 6 months)

  2. Clinical outcomes for sudden-death survivors undergoing head to pelvis CT scan

    Time frame: 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)

  3. Determine complications of cardiopulmonary resuscitation on thoracoabdominal organs measured by CT in sudden death survivors

    Time frame: During hospitalization (up to 6 months)

Other outcomes

  1. Safety outcome: Incidence of contrast associated acute kidney injury.

    Time frame: 48 hours from CT scan (up to 6 months)

  2. Safety outcome: Prevalence of false positive CT findings leading to incorrect treatment

    Time frame: During hospitalization (up to 6 months)

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Harborview Injury Prevention and Research Center
  • Medic One Foundation

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2021
First posted
Apr 12, 2017
Registry last updated
May 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.