Improving Syncope Risk Stratification in Older Adults
Public ClinicalTrials.gov record NCT01802398. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01802398
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 3,707 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 60 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 31, 2013
- Primary completion
- Sep 20, 2016
- Completion
- Dec 13, 2016
- Last update posted
- Jan 23, 2019
2013 – 2016
United States locations
- U.S. sites
- 10
- U.S. states
- 9
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California, Davis | UC Davis | Sacramento | California | 95817 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| Beaumont Health System | Royal Oak | Michigan | 48085 | — |
| URMC, Emergency Department | Rochester | New York | 14642 | — |
| Wakeforest, Department of Emergency Medicine | Winston-Salem | North Carolina | 27157 | — |
| Summa Health System, Department of Emergency Medicine (Research) | Akron | Ohio | 44304 | — |
| Ohio State University | Columbus | Ohio | 43210 | — |
| Oregon Health and Science University | Portland | Oregon | 97229 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 327232-4700 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01802398, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 23, 2019 · Synced Sep 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01802398 live on ClinicalTrials.gov.