Clinical Trial: Head-to-pelvis Computed Tomography Evaluation of Sudden Death Survivors

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Head-to-pelvis Computed Tomography Evaluation of Sudden Death Survivors

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 Summary: 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.
Sponsor: University of Washington

Current Primary Outcome:

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Determine adjudicated causes for sudden-death event in survivors [ Time Frame: During hospitalization (up to 6 months) ]
  • 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)
  • Determine complications of cardiopulmonary resuscitation on thoracoabdominal organs measured by CT in sudden death survivors [ Time Frame: During hospitalization (up to 6 months) ]


Original Secondary Outcome: Same as current

Information By: University of Washington

Dates:
Date Received: March 24, 2017
Date Started: December 1, 2015
Date Completion:
Last Updated: May 15, 2017
Last Verified: May 2017