- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01193998
Impact of Validated Diagnostic Prediction Model of Acute Heart Failure in the Emergency Department
June 12, 2014 updated by: Brian Steinhart, Unity Health Toronto
Analysis of the Impact of Using a Validated Diagnostic Prediction Model of Acute Heart Failure in the Emergency Department
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
186
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5B 1W8
- St. Michael's Hospital
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Waikato, New Zealand
- Waikato Hospital Cardiology Clinical Trials Unit
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Michigan
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Detroit, Michigan, United States, 48201
- Wayne State University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age ≥ 18 years
- Presentation to the ED with undifferentiated shortness of breath
Exclusion Criteria:
- Dyspnea of obvious cause, e.g. chest trauma, obvious clinical exacerbation of known chronic obstructive disease
- Obvious pulmonary edema in a patient with a known diagnosis of HF and recently admitted to hospital for HF
- Clinician does not plan to treat for AHF at all, but rather to pursue other causes of dyspnea (i.e., probability of AHF ≤ 20%)
- Clinician plans to treat for AHF and not to pursue other causes of dyspnea (i.e., probability of AHF ≥ 80%)
- Acute coronary syndrome within one month
- Chronic renal failure (serum creatinine ≥ 250 mol/l)
- Anticipated life expectancy < 6 months due to non-cardiovascular causes
- Participation in another interventional outcome trial
- Inability to obtain informed consent, including inability of patient to understand English
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Clinician exposed to Model result
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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).
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Experimental: Clinician blinded to Model result
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Comparison of diagnostic model versus clinical judgment in appropriate diagnosis of Acute Heart Failure in dyspneic emergency department patients
Time Frame: 60 days after patient presentation to the emergency department
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60 days after patient presentation to the emergency department
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determine if use of the diagnostic prediction model leads to cost savings and better health outcomes
Time Frame: From randomization until 60 days after patient presentation to the emergency department
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From randomization until 60 days after patient presentation to the emergency department
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: David Mazer, MD, Unity Health Toronto
- Principal Investigator: Brian Steinhart, MD, Unity Health Toronto
- Principal Investigator: Gordon Moe, MD, Unity Health Toronto
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
September 1, 2010
First Submitted That Met QC Criteria
September 1, 2010
First Posted (Estimate)
September 2, 2010
Study Record Updates
Last Update Posted (Estimate)
June 16, 2014
Last Update Submitted That Met QC Criteria
June 12, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09-310
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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