NCT01802398

Improving Syncope Risk Stratification in Older Adults

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,707 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Syncope

Timeline

• Start date: 2013-04-01
• Primary completion: 2016-09-21
• Completion: 2016-12-14
• First posted: 2013-03-01
• Last updated: 2019-01-24

Locations

10 sites across 1 country: United States