Improving Syncope Risk Stratification in Older Adults (SRS)

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease
Syncope

Study Design

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Study Type :	Observational
Actual Enrollment :	3707 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Improving Syncope Risk Stratification in Older Adults
Study Start Date :	April 2013
Actual Primary Completion Date :	September 21, 2016
Actual Study Completion Date :	December 14, 2016

Groups and Cohorts

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Group/Cohort
No treatment; Observational cohort study of older (age≥60 years) adults who present to an emergency department with syncope (otherwise known as fainting)

Outcome Measures

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Primary Outcome Measures :

1. Combined death and serious cardiac events [ Time Frame: 30 days ]
   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.

Other Outcome Measures:

1. Non-cardiac serious events [ Time Frame: 30-days ]

Biospecimen Retention:   Samples Without DNA

Serum samples will be collected for standardized cardiac biomarker testing. Samples will be split into two aliquots for testing and long-term storage. Aliquots in long-term -80˚C storage will be used for future studies of novel tests.

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	60 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Emergency Departments (ED)

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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, California
University of California, Davis | UC Davis
Sacramento, California, United States, 95817
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Michigan
Beaumont Health System
Troy and Royal Oak, Michigan, United States, 48085
United States, New York
URMC, Emergency Department
Rochester, New York, United States, 14642
United States, North Carolina
Wakeforest, Department of Emergency Medicine
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Summa Health System, Department of Emergency Medicine (Research)
Akron, Ohio, United States, 44304
Ohio State University
Columbus, Ohio, United States, 43210
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97229
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 327232-4700

Sponsors and Collaborators

Oregon Health and Science University

National Institutes of Health (NIH)

Investigators

Principal Investigator:	Benjamin C Sun, MD	Oregon Health and Science University

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Benjamin Sun, Associate Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier:	NCT01802398 History of Changes
Other Study ID Numbers:	NIH R01 HL111033-01A1
First Posted:	March 1, 2013
Last Update Posted:	April 4, 2017
Last Verified:	April 2017

Keywords provided by Benjamin Sun, Oregon Health and Science University:

Risk Stratification; Syncope; Geriatric

Additional relevant MeSH terms:

Syncope; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations	Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms