Impact of Validated Diagnostic Prediction Model of Acute Heart Failure in the Emergency Department
This study is currently recruiting participants.
Verified December 2012 by St. Michael's Hospital, Toronto
Sponsor:
St. Michael's Hospital, Toronto
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Brian Steinhart, St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT01193998
First received: September 1, 2010
Last updated: December 14, 2012
Last verified: December 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Dyspnea Acute Heart Failure Shortness of Breath |
Other: Treatment as per model probability Other: Treatment as per usual care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Diagnostic |
| Official Title: | Analysis of the Impact of Using a Validated Diagnostic Prediction Model of Acute Heart Failure in the Emergency Department |
Resource links provided by NLM:
Further study details as provided by St. Michael's Hospital, Toronto:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 150 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Clinician exposed to Model result |
Other: Treatment as per model probability
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).
|
| Experimental: Clinician blinded to Model result |
Other: Treatment as per usual care
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01193998
Contacts
| Contact: Brian Steinhart, MD | 416-864-5095 | STEINHARTB@smh.ca |
Locations
| United States, Michigan | |
| Wayne State University | Recruiting |
| Detroit, Michigan, United States, 48201 | |
| Contact: Jessica Hopkins, RN 313-745-4238 | |
| Principal Investigator: Phillip Levy, MD | |
| Canada, Ontario | |
| St. Michael's Hospital | Recruiting |
| Toronto, Ontario, Canada, M5B 1W8 | |
| Principal Investigator: Brian Steinhart, MD | |
| New Zealand | |
| Waikato Hospital Cardiology Clinical Trials Unit | Recruiting |
| Waikato, New Zealand | |
| Contact: Liz Low 07 839 7136 | |
| Principal Investigator: Gerard Devlin, MD | |
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Roche Pharma AG
Investigators
| Principal Investigator: | Brian Steinhart, MD | St. Michael's Hospital, Toronto |
| Principal Investigator: | David Mazer, MD | St. Michael's Hospital, Toronto |
| Principal Investigator: | Gordon Moe, MD | St. Michael's Hospital, Toronto |
More Information
Publications:
| Responsible Party: | Brian Steinhart, Physician, St. Michael's Hospital, Toronto |
| ClinicalTrials.gov Identifier: | NCT01193998 History of Changes |
| Other Study ID Numbers: | 09-310 |
| Study First Received: | September 1, 2010 |
| Last Updated: | December 14, 2012 |
| Health Authority: | Canada: Ethics Review Committee |
Additional relevant MeSH terms:
|
Dyspnea Emergencies Heart Failure Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Disease Attributes Pathologic Processes Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 22, 2013