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Sudden DeathNCT03111043

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

An observational study of Sudden Death and Out-Of-Hospital Cardiac Arrest, run by University of Washington at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sudden Death, Out-Of-Hospital Cardiac Arrest
What is being tested?
Head to pelvis CT scan
How many people
104 participants
Where
2 sitesUnited States
Study dates
1 Dec 2015to 1 Jul 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Harborview Medical Center

    Seattle, Washington, 98195

  • University of Washington

    Seattle, Washington, 98195

Other trials in United States

About this study

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.

Read the 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.

Being tested
Head to pelvis CT scan
Keywords
computed tomography, Sudden cardiac arrest, Cardiac computed tomography, Diagnostic accuracy, Clinical outcome
Medical subject headings
Death, Sudden, Out-of-Hospital Cardiac Arrest, Death, Sudden, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Head to pelvis CT scanDiagnostic 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)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diagnostic accuracy compared to adjudicated diagnosis for sudden-death event

    Measured: During hospitalization (up to 6 months)

  2. Time to correct diagnosis by head to pelvis CT scan

    Measured: During hospitalization (up to 6 months)

  3. Cost analysis of head to pelvis CT scan - payer perspective

    Measured: During hospitalization (up to 6 months)

Secondary outcomes (3)

  1. Determine adjudicated causes for sudden-death event in survivors

    Measured: During hospitalization (up to 6 months)

  2. 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)

    Measured: During hospitalization (up to 6 months)

  3. Determine complications of cardiopulmonary resuscitation on thoracoabdominal organs measured by CT in sudden death survivors

    Measured: During hospitalization (up to 6 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2017
  2. Study start1 Dec 2015
  3. Primary completion15 Feb 2018
  4. Study completion1 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
104 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03111043
Sponsor's protocol ID
STUDY00001380
Status last verified
May 2024
First submitted
24 Mar 2017
Last updated
9 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Unclear plan for sharing data.

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.

    PubMed 33606342

  • 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.

    PubMed 32422241

  • 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.

    PubMed 35043689

  • 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.

    PubMed 37019352

Questions about this trial

What is this clinical trial studying?

An observational study of Sudden Death and Out-Of-Hospital Cardiac Arrest, run by University of Washington at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnostic accuracy compared to adjudicated diagnosis for sudden-death event (time frame: During hospitalization (up to 6 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03111043, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.

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