Assessment of Acute Disease to Reduce Imaging Costs (QUAADRICs)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01059500 |
Recruitment Status :
Completed
First Posted : February 1, 2010
Last Update Posted : February 17, 2016
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Condition or disease | Intervention/treatment | Phase |
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Acute Coronary Syndrome Pulmonary Embolism | Device: Pilot Phase Device: Intervention group, receive the numeric PTP estimate Device: No Intervention | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 850 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Screening |
Official Title: | Quantitative Pretest Probability to Reduce Cardiopulmonary Imaging in the ED |
Study Start Date : | January 2010 |
Actual Primary Completion Date : | May 2012 |
Actual Study Completion Date : | February 2013 |
Arm | Intervention/treatment |
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Pilot Phase
First 300 patients will be assigned to arm 1 to test the accuracy of the webtool output.
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Device: Pilot Phase
Non-intervention phase to test webtool technical reliability, accurate low PTP, and calibration. Device: No Intervention Standard (no webtool output) |
Experimental: Webtool output
Phase 2- Intervention, One group will receive the numeric PTP estimate from webtool output, the other groupwill not receive the nemuric PTP estimate
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Device: Intervention group, receive the numeric PTP estimate
Receive the numeric PTP estimate for ACS and PE, and one of three testing recommendations. For ACS, PTP <2.5% with low clinical suspicion and available follow-up, no further testing; PTP 2.5 to 5.5%: obtain a troponin I measurement at presentation and 120 minutes later, and if both are normal, no further testing; PTP >5.5%: proceed to provocative testing. For PE, PTP<2.5% with low clinical suspicion and available follow-up, no further testing; PTP 2.5-10%, obtain a quantitative D-dimer and if normal, no further testing. PTP 10-20%, proceed directly to pulmonary vascular imaging, and if PTP>20% consider empiric anticoagulation with heparin if no contraindications. |
- Primary measurements will test if the webtool works properly(observational): A. Technical reliability B. Accurate low PTP C. Calibration [ Time Frame: After 300 patients enrolled ]
- A. Quality: B. Effectiveness: C. Efficiency: D. Safety: E. Patient satisfaction: [ Time Frame: 2 years ]

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Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01059500
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02215 | |
United States, Mississippi | |
University of Mississippi Medical Center | |
Jackson, Mississippi, United States, 39216 | |
United States, North Carolina | |
Carolinas Medical Center | |
Charlotte, North Carolina, United States, 28203 | |
Forsyth Medical Center | |
Winston-Salem, North Carolina, United States, 27103 |
Principal Investigator: | Jeffrey A Kline, MD | Indiana University School of Medicine |
Responsible Party: | Jeffrey Kline, Research Director, Atrium Health |
ClinicalTrials.gov Identifier: | NCT01059500 |
Other Study ID Numbers: |
1R18HS018519-01 ( U.S. AHRQ Grant/Contract ) |
First Posted: | February 1, 2010 Key Record Dates |
Last Update Posted: | February 17, 2016 |
Last Verified: | February 2016 |
Computer-derived, quantitative pretest probability (PTP) Overtesting Radiation Intravenous Contrast Anticoagulation |
Pulmonary Embolism Acute Coronary Syndrome Embolism Myocardial Ischemia Heart Diseases |
Cardiovascular Diseases Vascular Diseases Embolism and Thrombosis Lung Diseases Respiratory Tract Diseases |