An observational study in Syncope, sponsored by University of Pennsylvania. Completed at 10 sites in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2019-01-24.
Sponsored by University of Pennsylvania · Observational
Syncope (temporary loss of consciousness) is a frequent reason for an emergency department (ED) visit among older adults. The current ED evaluation of syncope frequently leads to hospitalization, results in low diagnostic yield, and is enormously costly. The purpose of this protocol is to improve risk prediction for syncope. Improved risk prediction will inform the design of interventions to safely reduce unnecessary health service use.
This is a multi-center, prospective, observational cohort study of older (age≥60 years) adults who present to an emergency department with syncope (otherwise known as fainting). The primary outcome is a composite of 30-day cardiac death and serious cardiac events.
Study Aims and Hypotheses are:
Specific Aim 1. Describe serious outcomes after unexplained syncope; rates and reasons for admission; and frequency, diagnostic yield, and therapeutic impact of inpatient diagnostic tests.
H1: Current patterns of care representing a diversity of practice settings and patient populations are costly with low clinical benefit.
Specific Aim 2. Derive and validate a novel risk prediction model for 30-day cardiac death and serious cardiac outcomes after unexplained syncope.
H2: Explicit criteria including contemporary cardiac biomarkers will improve risk stratification compared to unstructured physician assessment and published risk models.
Specific Aim 3. Assess safety and costs of a risk-tailored diagnostic algorithm compared to existing care for unexplained syncope.
H3: A risk-tailored diagnostic algorithm can safely reduce the costs of evaluating unexplained syncope in older adults.
232 studies on the registry are indexed under Syncope; 45 are open to participants now.
This study's enrollment of 3,707 is above the median of 235 across 95 observational studies indexed under Syncope.
Browse Syncope studies →University of Pennsylvania is the lead sponsor of 1,664 studies on the registry; 236 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 107 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Emergency Departments (ED)
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Exclusion Criteria:
Observational cohort study of older (age≥60 years) adults who present to an emergency department with syncope (otherwise known as fainting)
Combined death and serious cardiac events
This aim tests the hypothesis that current patterns of care are costly with low clinical benefit. We will generate tables that describe the demographics, clinical characteristics, and disposition of the study cohort, stratified by occurrence of the primary outcome. Outcomes experienced by the study cohort will be described in detail.
Time frame: 30 days
Non-cardiac serious events
Time frame: 30-days
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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