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| Name | Class |
|---|---|
| Medic One Foundation | OTHER |
| Harborview Injury Prevention and Research Center | OTHER |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Clinical outcomes include in-hospital survival, circulatory arrest, survival to discharge, and discharge status (discharge to home, nursing facility) |
| Measure | Description | Time 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 treatment | During hospitalization (up to 6 months) |
Inclusion Criteria:
Exclusion Criteria:
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Individuals in the Seattle Fire Department or King County, Washington Emergency Medical Services service area
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| Name | Affiliation | Role |
|---|---|---|
| Kelley Branch, MD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harborview Medical Center | Seattle | Washington | 98195 | United States | ||
| University of Washington |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33606342 | Background | 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. | |
| 32422241 |
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Unclear plan for sharing data.
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| ID | Term |
|---|---|
| D003645 | Death, Sudden |
| D058687 | Out-of-Hospital Cardiac Arrest |
| D016757 | Death, Sudden, Cardiac |
| ID | Term |
|---|---|
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006323 | Heart Arrest |
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| During hospitalization (up to 6 months) |
| Determine complications of cardiopulmonary resuscitation on thoracoabdominal organs measured by CT in sudden death survivors | During hospitalization (up to 6 months) |
| Seattle |
| Washington |
| 98195 |
| United States |
| 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. |
| 35043689 | Background | 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. |
| 37019352 | Background | 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. |
| D006331 |
| Heart Diseases |
| D002318 | Cardiovascular Diseases |