Comprehensive Cardiothoracic Dual Source CT for the Early Triage of Patients With Acute Chest Pain
Condition: Chest Pain Syndrome
MeSH terms: Chest Pain
Intervention: Comprehensive Cardiothoracic CT arm
Intervention description: Subjects in this arm will receive the comprehensive cardiothoracic CT to rule out aortic dissection/pulmonary embolism/acute coronary syndrome in a single scan.
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized diagnostic trial, two arms
Masking: None (Open Label)
Enrollment: 59.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No

Summary:

      The purpose of this research is to determine the efficiency of a single dual source computed
      tomography (CT-DSCT) protocol to establish or exclude acute coronary syndrome (ACS),
      pulmonary embolism (PE) or aortic dissection (AD) as compared to the individual protocols.
      Endpoints aim to compare the rate of emergency department (ED) discharge, length of hospital
      stay, the diagnostic imaging test utilization, and the costs between the comprehensive and
      the standard protocol strategy in patients with undifferentiated chest discomfort or
      shortness of breath with a component of chest discomfort.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females >30 years of age in sinus rhythm

          -  Willing and able to provide written informed consent

          -  Undifferentiated chest discomfort or shortness of breath with a component of chest
             discomfort within the last 24 hours

          -  Intermediate likelihood of MI, pulmonary embolism (PE), or aortic dissection (AD) as
             determined by ED providers after completion of standard initial clinical evaluation

          -  ED providers independently decide that the patient's care plan should include a
             coronary, PE, or AD CT.

          -  Female patients must be either of non-childbearing potential (i.e., surgically
             sterilized or post menopausal [≥ 12 consecutive months without menses]) or must have a
             negative pregnancy test

        Exclusion Criteria:

          -  Positive cardiac biomarkers (elevated serum creatine phosphate (CK) with elevated
             CK-MB isoform and/or elevated troponin)

          -  Diagnostic ECG changes (e.g., >1 mm ST-segment elevation or depression in two
             anatomically contiguous leads)

          -  Known history of CAD (i.e., past myocardial infarction, prior coronary stent
             Placement, and/or coronary artery bypass graft surgery)

          -  Known history of thoracic aortic disease (i.e., thoracic aortic aneurysm > 5cm in
             diameter, history of aortic dissection, and/or history of thoracic aortic aneurysm
             repair (via open surgery or stent-graft placement))

          -  Known history of pulmonary embolism

          -  Heart rate > 100 beats per minute

          -  Systolic blood pressure <105 mmHg

          -  Oxygen saturation < 90%

          -  Any cardiac arrhythmia causing hemodynamic compromise

          -  Serum creatinine clearance <60 mL/min by Cockcroft-Gault

          -  Known allergy to iodinated contrast agents

          -  Subjects on metformin therapy that are unable or unwilling to discontinue therapy for
             48 hours after CT procedure