Status:
COMPLETED
Evaluating an Emergency Department Observation Syncope Protocol for Older Adults
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
University of Southern California
Brigham and Women's Hospital
Conditions:
Syncope
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
Syncope, defined as a transient loss of consciousness, accounts for over 700,000 annual U.S. emergency department visits and may herald a life-threatening condition in older adults (age≥60 years). Exi...
Eligibility Criteria
Inclusion
- Age≥60 years
- A complaint of syncope or near-syncope (Syncope is defined as a sudden, transient loss of consciousness. Near-syncope is defined as a sensation of imminent loss of consciousness, without actual syncope.)
- Intermediate risk of adverse outcome (see Table)
- Patient speaks either English or Spanish as a primary language.
Exclusion
- Syncope mimics (intoxication, weakness or dizziness with syncope/ near-syncope, hypoglycemia, and cardiac arrest)
- New or baseline cognitive impairment or dementia)
- Inability to provide follow-up information (e.g. homeless or resides outside of U.S.)
- Inability to speak Spanish or English
- Low- and high-risk patients (see Table).
- Risk Stratification Guidelines:
- High Risk
- Serious condition identified in ED
- History of ventricular arrhythmia
- Cardiac Device with dysfunction
- Presentation consistent with acute coronary ischemia
- Intermediate Risk
- No High Risk features
- Presentation not consistent with orthostatic or vasovagal syncope
- Low Risk
- Presentation consistent with orthostatic or vasovagal syncope
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT01003262
Start Date
March 1 2010
End Date
December 1 2011
Last Update
February 13 2023
Active Locations (4)
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1
University of Southern California
Los Angeles, California, United States
2
Brigham and Women's Hospital
Boston, Massachusetts, United States
3
William Beaumont Hospital
Royal Oaks, Michigan, United States, 48073
4
Duke University Medical Center
Durham, North Carolina, United States, 27705