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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

104 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-01

Study Completion Date

2021-07-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Sudden Death Out-Of-Hospital Cardiac Arrest

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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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)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No