Clinical trial NCT01802398: Improving Syncope Risk Stratification in Older Adults
Official title: Improving Syncope Risk Stratification in Older Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Syncope
Keywords: Risk Stratification
Syncope
Geriatric
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2013-03-01
Enrollment: 3707
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Emergency Departments (ED)

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Combined death and serious cardiac events
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
measure: Non-cardiac serious events
timeFrame: 30-days
Locations:
city: Sacramento
country: United States
facility: University of California, Davis | UC Davis
state: California
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Royal Oak
country: United States
facility: Beaumont Health System
state: Michigan
city: Rochester
country: United States
facility: URMC, Emergency Department
state: New York
city: Winston-Salem
country: United States
facility: Wakeforest, Department of Emergency Medicine
state: North Carolina
city: Akron
country: United States
facility: Summa Health System, Department of Emergency Medicine (Research)
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Oregon Health and Science University
name: Benjamin C Sun, MD
role: PRINCIPAL_INVESTIGATOR
References:
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