Improving Syncope Risk Stratification in Older Adults

Syncope Clinical Trial

— SRS  

Official title:

Improving Syncope Risk Stratification in Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01802398
• Other study ID #: NIH R01 HL111033-01A1
• Status: Completed
• Start date: April 2013
• Est. completion date: December 14, 2016

Study information

• Verified date: January 2019
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3707
• Est. completion date: December 14, 2016
• Est. primary completion date: September 21, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

1. age=60 years; AND

2. a complaint of syncope or near-syncope. Syncope is defined as a transient loss of consciousness (LOC), associated with loss of postural tone, with immediate, spontaneous, and complete recovery. Near-syncope is the sensation of imminent syncope without loss of consciousness.

Exclusion Criteria:

• Seizure as presumptive cause of LOC

• Stroke or transient ischemic attack as presumptive cause of LOC

• LOC AFTER head trauma Confusion from baseline mental status

• Intoxicated (alcohol or other drugs)

• Medical or electrical intervention to restore consciousness

• Hypoglycemia as presumptive cause of LOC

• inability to provide follow-up information, including patients who do not speak English (or Spanish, if applicable for study site), lack phone access, or lack a permanent address

• Inability or unwillingness of individual or legal guardian/representative to give written informed consent

Related Conditions & MeSH terms

• Syncope

Locations

Country	Name	City	State
United States	Summa Health System, Department of Emergency Medicine (Research)	Akron	Ohio
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Ohio State University	Columbus	Ohio
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Oregon Health and Science University	Portland	Oregon
United States	URMC, Emergency Department	Rochester	New York
United States	Beaumont Health System	Royal Oak	Michigan
United States	University of California, Davis | UC Davis	Sacramento	California
United States	Wakeforest, Department of Emergency Medicine	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Non-cardiac serious events		30-days
Primary	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.	30 days