View Clinical Trial (Medical Research Study)
Quantitative Pretest Probability to Reduce Cardiopulmonary Imaging in the ED
| City: |
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Charlotte |
| State: |
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North Carolina |
| Zip Code: |
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28203 |
| Conditions: |
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Acute Coronary Syndrome - Pulmonary Embolism |
| Purpose: |
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Overtesting for Acute Coronary Syndrome(ACS) and Pulmonary Embolism (PE) in low risk
Emergency Department(ED) patients can increase exposure of nondiseased patients to
radiation, intravenous contrast and anticoagulation. This project addresses question of
whether quantitative Pre-Test Probability(PTP) assessed from two validated web-based
computer algorithms (the project "webtool"), can improve the diagnostic evaluation of adult
patients with charted evidence of chest pain and dyspnea. After a validation phase, the
main study will randomize patients to either the Standard care group or the Intervention
group, which will receive the output of the ACS and PE webtool that includes the PTP
estimates of ACS and PE and one of three recommendations regarding next steps: 1. No further
testing, 2. Exclusion with a biomarker protocol, or 3. Immediate imaging +/- empiric
anticoagulation.
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| Study Summary: |
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| Criteria: |
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I. Inclusion criteria
- Adult (>17 years) ED patient reports a history of chest discomfort and new or
worsened shortness of breath or breathing difficulty, documented in the written
history of present illness or review of systems.
- Patient must understand English or have a certified translator present.
- Physician has ordered or plans to order a 12-lead electrocardiogram.
- Patient indicates the site hospital was his or her "hospital of choice" in the event
of return visit within 14 days.
II. Pre-randomization exclusion criteria
- 12-lead ECG with ST deviation interpreted as acute infarction or ischemia.
- Known diagnosis of acute PE within previous 24 hours (e.g., call back for overread of
a CT scan).
- "Code STEMI" patients (patients with suspected acute myocardial infarction).
- Other obvious condition or diagnosis identified by the emergency physician as
mandating admission (evidence of circulatory shock, severe hypoxemia, decompensated
heart failure, altered mental status, hemorrhage, sepsis syndrome, arrhythmia,
trauma, unstable social or psychiatric situation, stroke, aortic disaster, pneumonia
).
- Myocardial infarction, intracoronary stent placement, or CABG within the previous 30
days.
- Known cocaine use within past 72 hours, based upon patient or laboratory report.
- Referral to the emergency department by a personal physician.
- Patients undergoing voluntary medical clearance for a detox center or any involuntary
court or magistrate order.
- Computer interpretation of the 12-lead ECG containing either "ischemia" or
"infarction".
- Homelessness, out-of-town residence or other condition known to preclude follow-up in
14 days.
- Patients in police custody or currently incarcerated individuals.
- Patients who know they are pregnant or in whom a pregnancy test was drawn as part of
usual care and was found to be positive.
III. Post-randomization exclusions
- Positive urine cocaine test.
- Incarceration within 14 days of enrollment.
- Patient elopement from medical care (i.e., patients who leave against medical
advice).
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| NCT ID: |
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NCT01059500 |
| Primary Contact: |
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Principal Investigator
Jeffrey A Kline, MD
Carolinas Healthcare System
Jackeline Hernandez
Phone: 704-355-2612
Email: jackeline.hernandez@carolinas.org
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| Backup Contact: |
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N/A |
| Location Contact: |
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Charlotte, North Carolina 28203
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 22, 2013 |
| Modifications to this listing: |
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