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Improving Syncope Risk Stratification in Older Adults (SRS)
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Purpose
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 |
|---|
| Syncope |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Improving Syncope Risk Stratification in Older Adults |
- 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.
- Non-cardiac serious events [ Time Frame: 30-days ]
Biospecimen Retention: Samples Without DNA
| Enrollment: | 3707 |
| Study Start Date: | April 2013 |
| Study Completion Date: | December 14, 2016 |
| Primary Completion Date: | September 21, 2016 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
No treatment
Observational cohort study of older (age≥60 years) adults who present to an emergency department with syncope (otherwise known as fainting)
|
Eligibility| Ages Eligible for Study: | 60 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- age≥60 years; AND
- 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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01802398
| 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 | |
| Principal Investigator: | Benjamin C Sun, MD | Oregon Health and Science University |
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 |
| Study First Received: | February 27, 2013 |
| Last Updated: | April 3, 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 |
ClinicalTrials.gov processed this record on August 18, 2017