- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03111043
Head-to-pelvis Computed Tomography Evaluation of Sudden Death Survivors
May 8, 2023 updated by: Kelley Branch, University of Washington
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
104
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98195
- University of Washington
-
Seattle, Washington, United States, 98195
- Harborview Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Diagnostic accuracy compared to adjudicated diagnosis for sudden-death event
Time Frame: During hospitalization (up to 6 months)
|
During hospitalization (up to 6 months)
|
Time to correct diagnosis by head to pelvis CT scan
Time Frame: During hospitalization (up to 6 months)
|
During hospitalization (up to 6 months)
|
Cost analysis of head to pelvis CT scan - payer perspective
Time Frame: During hospitalization (up to 6 months)
|
During hospitalization (up to 6 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determine adjudicated causes for sudden-death event in survivors
Time Frame: During hospitalization (up to 6 months)
|
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)
|
During hospitalization (up to 6 months)
|
Determine complications of cardiopulmonary resuscitation on thoracoabdominal organs measured by CT in sudden death survivors
Time Frame: During hospitalization (up to 6 months)
|
During hospitalization (up to 6 months)
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety outcome: Incidence of contrast associated acute kidney injury.
Time Frame: 48 hours from CT scan (up to 6 months)
|
48 hours from CT scan (up to 6 months)
|
Safety outcome: Prevalence of false positive CT findings leading to incorrect treatment
Time Frame: During hospitalization (up to 6 months)
|
During hospitalization (up to 6 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kelley Branch, MD, University of Washington
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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 Apr 3:109785. doi: 10.1016/j.resuscitation.2023.109785. Online ahead of print.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2015
Primary Completion (Actual)
February 15, 2018
Study Completion (Actual)
July 1, 2021
Study Registration Dates
First Submitted
March 24, 2017
First Submitted That Met QC Criteria
April 5, 2017
First Posted (Actual)
April 12, 2017
Study Record Updates
Last Update Posted (Actual)
May 10, 2023
Last Update Submitted That Met QC Criteria
May 8, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00001380
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Unclear plan for sharing data.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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