Head-to-pelvis Computed Tomography Evaluation of Sudden Death Survivors
Primary Purpose
Sudden Death, Out-Of-Hospital Cardiac Arrest
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Head to pelvis CT scan
Sponsored by
About this trial
This is an interventional diagnostic trial for Sudden Death focused on measuring computed tomography, Sudden cardiac arrest, Cardiac computed tomography, Diagnostic accuracy, Clinical outcome
Eligibility Criteria
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
Sites / Locations
- Harborview Medical Center
- University of Washington
Outcomes
Primary Outcome Measures
Diagnostic accuracy compared to adjudicated diagnosis for sudden-death event
Time to correct diagnosis by head to pelvis CT scan
Cost analysis of head to pelvis CT scan - payer perspective
Secondary Outcome Measures
Determine adjudicated causes for sudden-death event in survivors
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)
Determine complications of cardiopulmonary resuscitation on thoracoabdominal organs measured by CT in sudden death survivors
Full Information
NCT ID
NCT03111043
First Posted
March 24, 2017
Last Updated
May 8, 2023
Sponsor
University of Washington
Collaborators
Medic One Foundation, Harborview Injury Prevention and Research Center
1. Study Identification
Unique Protocol Identification Number
NCT03111043
Brief Title
Head-to-pelvis Computed Tomography Evaluation of Sudden Death Survivors
Official Title
Head-to-pelvis Computed Tomography Evaluation of Sudden Death Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2015 (Actual)
Primary Completion Date
February 15, 2018 (Actual)
Study Completion Date
July 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
Medic One Foundation, Harborview Injury Prevention and Research Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sudden Death, Out-Of-Hospital Cardiac Arrest
Keywords
computed tomography, Sudden cardiac arrest, Cardiac computed tomography, Diagnostic accuracy, Clinical outcome
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pre- post-CT scanning protocol cohort analysis
Masking
InvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Diagnostic Test
Intervention Name(s)
Head to pelvis CT scan
Intervention Description
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 Outcome Measure Information:
Title
Diagnostic accuracy compared to adjudicated diagnosis for sudden-death event
Time Frame
During hospitalization (up to 6 months)
Title
Time to correct diagnosis by head to pelvis CT scan
Time Frame
During hospitalization (up to 6 months)
Title
Cost analysis of head to pelvis CT scan - payer perspective
Time Frame
During hospitalization (up to 6 months)
Secondary Outcome Measure Information:
Title
Determine adjudicated causes for sudden-death event in survivors
Time Frame
During hospitalization (up to 6 months)
Title
Clinical outcomes for sudden-death survivors undergoing head to pelvis CT scan
Description
Clinical outcomes include in-hospital survival, circulatory arrest, survival to discharge, and discharge status (discharge to home, nursing facility)
Time Frame
During hospitalization (up to 6 months)
Title
Determine complications of cardiopulmonary resuscitation on thoracoabdominal organs measured by CT in sudden death survivors
Time Frame
During hospitalization (up to 6 months)
Other Pre-specified Outcome Measures:
Title
Safety outcome: Incidence of contrast associated acute kidney injury.
Time Frame
48 hours from CT scan (up to 6 months)
Title
Safety outcome: Prevalence of false positive CT findings leading to incorrect treatment
Time Frame
During hospitalization (up to 6 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelley Branch, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Unclear plan for sharing data.
Citations:
PubMed Identifier
33606342
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.
Results Reference
background
PubMed Identifier
32422241
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.
Results Reference
background
PubMed Identifier
35043689
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.
Results Reference
background
PubMed Identifier
37019352
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.
Results Reference
background
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Head-to-pelvis Computed Tomography Evaluation of Sudden Death Survivors
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