Clinical trial NCT03111043: Head-to-pelvis Computed Tomography Evaluation of Sudden Death Survivors
Official title: Head-to-pelvis Computed Tomography Evaluation of Sudden Death Survivors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sudden Death
Out-Of-Hospital Cardiac Arrest
Keywords: computed tomography
Sudden cardiac arrest
Cardiac computed tomography
Diagnostic accuracy
Clinical outcome
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Medic One Foundation
name: Harborview Injury Prevention and Research Center
First posted: 2017-04-12
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals in the Seattle Fire Department or King County, Washington Emergency Medical Services service area

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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic accuracy compared to adjudicated diagnosis for sudden-death event
timeFrame: During hospitalization (up to 6 months)
measure: Time to correct diagnosis by head to pelvis CT scan
timeFrame: During hospitalization (up to 6 months)
measure: Cost analysis of head to pelvis CT scan - payer perspective
timeFrame: During hospitalization (up to 6 months)
Secondary outcomes:
measure: Determine adjudicated causes for sudden-death event in survivors
timeFrame: During hospitalization (up to 6 months)
measure: Clinical outcomes for sudden-death survivors undergoing head to pelvis CT scan
timeFrame: During hospitalization (up to 6 months)
measure: Determine complications of cardiopulmonary resuscitation on thoracoabdominal organs measured by CT in sudden death survivors
timeFrame: During hospitalization (up to 6 months)
Other outcomes:
measure: Safety outcome: Incidence of contrast associated acute kidney injury.
timeFrame: 48 hours from CT scan (up to 6 months)
measure: Safety outcome: Prevalence of false positive CT findings leading to incorrect treatment
timeFrame: During hospitalization (up to 6 months)
Locations:
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Kelley Branch, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Branch KRH, Strote J, Gunn M, Maynard C, Kudenchuk PJ, Brusen R, Petek BJ, Sayre MR, Edwards R, Carlbom D, Counts CR, Probstfield JL, Gatewood MO. Early head-to-pelvis computed tomography in out-of-hospital circulatory arrest without obvious etiology. Acad Emerg Med. 2021 Apr;28(4):394-403. doi: 10.1111/acem.14228. Epub 2021 Mar 24.
citation: Branch KR, Hira R, Brusen R, Maynard C, Kudenchuk PJ, Petek BJ, Strote J, Sayre MR, Gatewood M, Carlbom D, Counts C, Probstfield JL, Gunn M. Diagnostic accuracy of early computed tomographic coronary angiography to detect coronary artery disease after out-of-hospital circulatory arrest. Resuscitation. 2020 Aug;153:243-250. doi: 10.1016/j.resuscitation.2020.04.033. Epub 2020 May 15.
citation: Karatasakis A, Sarikaya B, Liu L, Gunn ML, Kudenchuk PJ, Gatewood MO, Maynard C, Sayre MR, Counts CR, Carlbom DJ, Edwards RM, Branch KRH. Prevalence and Patterns of Resuscitation-Associated Injury Detected by Head-to-Pelvis Computed Tomography After Successful Out-of-Hospital Cardiac Arrest Resuscitation. J Am Heart Assoc. 2022 Feb;11(3):e023949. doi: 10.1161/JAHA.121.023949. Epub 2022 Jan 19.
citation: Branch KRH, Gatewood MO, Kudenchuk PJ, Maynard C, Sayre MR, Carlbom DJ, Edwards RM, Counts CR, Probstfield JL, Brusen R, Johnson N, Gunn ML. Diagnostic yield, safety, and outcomes of Head-to-pelvis sudden death CT imaging in post arrest care: The CT FIRST cohort study. Resuscitation. 2023 Jul;188:109785. doi: 10.1016/j.resuscitation.2023.109785. Epub 2023 Apr 3.