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| Name | Class |
|---|---|
| Roche Pharma AG | INDUSTRY |
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The purpose of this study is to evaluate a validated diagnostic prediction model in the appropriate diagnosis of Acute Heart Failure (AHF) in patients presenting at the emergency department with undifferentiated dyspnea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinician exposed to Model result | Active Comparator |
| |
| Clinician blinded to Model result | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment as per model probability | Other | Patients randomized to the arm where the clinician is exposed to the model results should be treated as per the model probability (i.e. if the model probability suggests AHF the clinician should treat for AHF). |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of diagnostic model versus clinical judgment in appropriate diagnosis of Acute Heart Failure in dyspneic emergency department patients | 60 days after patient presentation to the emergency department |
| Measure | Description | Time Frame |
|---|---|---|
| Determine if use of the diagnostic prediction model leads to cost savings and better health outcomes | From randomization until 60 days after patient presentation to the emergency department |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Steinhart, MD | Unity Health Toronto | Principal Investigator |
| David Mazer, MD | Unity Health Toronto | Principal Investigator |
| Gordon Moe, MD | Unity Health Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wayne State University | Detroit | Michigan | 48201 | United States | ||
| St. Michael's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15820160 | Background | Januzzi JL Jr, Camargo CA, Anwaruddin S, Baggish AL, Chen AA, Krauser DG, Tung R, Cameron R, Nagurney JT, Chae CU, Lloyd-Jones DM, Brown DF, Foran-Melanson S, Sluss PM, Lee-Lewandrowski E, Lewandrowski KB. The N-terminal Pro-BNP investigation of dyspnea in the emergency department (PRIDE) study. Am J Cardiol. 2005 Apr 15;95(8):948-54. doi: 10.1016/j.amjcard.2004.12.032. | |
| 12135939 |
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| ID | Term |
|---|---|
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Treatment as per usual care | Other | Patients randomized to the arm where the clinician is blinded to the model results will undergo diagnostic tests and receive treatment as per the clinician's judgment and usual care standards. |
|
| Toronto |
| Ontario |
| M5B 1W8 |
| Canada |
| Waikato Hospital Cardiology Clinical Trials Unit | Waikato | New Zealand |
| Background |
| McCullough PA, Nowak RM, McCord J, Hollander JE, Herrmann HC, Steg PG, Duc P, Westheim A, Omland T, Knudsen CW, Storrow AB, Abraham WT, Lamba S, Wu AH, Perez A, Clopton P, Krishnaswamy P, Kazanegra R, Maisel AS. B-type natriuretic peptide and clinical judgment in emergency diagnosis of heart failure: analysis from Breathing Not Properly (BNP) Multinational Study. Circulation. 2002 Jul 23;106(4):416-22. doi: 10.1161/01.cir.0000025242.79963.4c. |
| 17548729 | Background | Moe GW, Howlett J, Januzzi JL, Zowall H; Canadian Multicenter Improved Management of Patients With Congestive Heart Failure (IMPROVE-CHF) Study Investigators. N-terminal pro-B-type natriuretic peptide testing improves the management of patients with suspected acute heart failure: primary results of the Canadian prospective randomized multicenter IMPROVE-CHF study. Circulation. 2007 Jun 19;115(24):3103-10. doi: 10.1161/CIRCULATIONAHA.106.666255. Epub 2007 Jun 4. |
| 19815122 | Background | Steinhart B, Thorpe KE, Bayoumi AM, Moe G, Januzzi JL Jr, Mazer CD. Improving the diagnosis of acute heart failure using a validated prediction model. J Am Coll Cardiol. 2009 Oct 13;54(16):1515-21. doi: 10.1016/j.jacc.2009.05.065. |
| D013568 | Pathological Conditions, Signs and Symptoms |