Head-to-pelvis Computed Tomography Evaluation of Sudden Death Survivors

NCT03111043 | Completed DMC

• 1 other identifier: STUDY00001380
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 2

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.

Conditions

Sudden Death; Out-Of-Hospital Cardiac Arrest

Keywords

computed tomography; Sudden cardiac arrest; Cardiac computed tomography; Diagnostic accuracy; Clinical outcome

Outcome Measures

Primary Outcomes (3)

• 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)

Secondary Outcomes (3)

• 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

  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)

Other Outcomes (2)

• 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)

Interventions

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals in the Seattle Fire Department or King County, Washington Emergency Medical Services service area

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• Medic One Foundation: collaborator
• Harborview Injury Prevention and Research Center: collaborator

Study Sites (2)

Harborview Medical Center

Seattle, Washington, 98195, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (4)

• 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.

  PMID: 33606342 BACKGROUND

• 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.

  PMID: 32422241 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.

  PMID: 35043689 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.

  PMID: 37019352 BACKGROUND

MeSH Terms

Conditions

Death, Sudden; Out-of-Hospital Cardiac Arrest; Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Arrest; Heart Diseases; Cardiovascular Diseases

Study Officials

• Kelley Branch, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Medicine/Cardiology

Study Record Dates

• First Submitted: March 24, 2017
• First Posted: April 12, 2017
• Study Start: December 1, 2015
• Primary Completion: February 15, 2018
• Study Completion: July 1, 2021
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)