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

Out-Of-Hospital Cardiac Arrest Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03111043
• Other study ID #: STUDY00001380
• Status: Completed
• Start date: December 1, 2015
• Est. completion date: July 1, 2021

Study information

• Verified date: May 2024
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 outcomes.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: July 1, 2021
• Est. primary completion date: February 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients reaching the Emergency Department within 6 hours of resuscitated sudden death.

2. No obvious cause for sudden death event with initial standard of care clinical evaluation

3. Clinically stable to have CT performed per treating physician

4. Candidates for continued intubation and sedation during the CT scan with or without therapeutic hypothermia protocol.

Exclusion Criteria:

1. 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

2. Obvious cause of sudden death - Examples: witnessed trauma, drowning, suicide attempt

3. Known non-revascularized coronary artery disease or coronary stent <2.5 mm.

4. Known severe renal dysfunction (eGFR<30 ml/hr, creatinine >1.7 mg/dl)

5. Implantable defibrillator, due to metal artifact from defibrillator coil

6. Known iodinated contrast allergy

7. Known hospice patient or terminal disease with expected <3 months survival

Related Conditions & MeSH terms

• Death
• Death, Sudden
• Heart Arrest
• Out-of-Hospital Cardiac Arrest
• Sudden Death

Intervention

Diagnostic Test:
• Head to pelvis CT scan
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)

Locations

Country	Name	City	State
United States	Harborview Medical Center	Seattle	Washington
United States	University of Washington	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
University of Washington	Harborview Injury Prevention and Research Center, Medic One Foundation

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety outcome: Incidence of contrast associated acute kidney injury.		48 hours from CT scan (up to 6 months)
Other	Safety outcome: Prevalence of false positive CT findings leading to incorrect treatment		During hospitalization (up to 6 months)
Primary	Diagnostic accuracy compared to adjudicated diagnosis for sudden-death event		During hospitalization (up to 6 months)
Primary	Time to correct diagnosis by head to pelvis CT scan		During hospitalization (up to 6 months)
Primary	Cost analysis of head to pelvis CT scan - payer perspective		During hospitalization (up to 6 months)
Secondary	Determine adjudicated causes for sudden-death event in survivors		During hospitalization (up to 6 months)
Secondary	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)	During hospitalization (up to 6 months)
Secondary	Determine complications of cardiopulmonary resuscitation on thoracoabdominal organs measured by CT in sudden death survivors		During hospitalization (up to 6 months)