Improving Syncope Risk Stratification in Older Adults (SRS)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified March 2016 by Oregon Health and Science University
Sponsor:
Oregon Health and Science University
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Benjamin Sun, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01802398
First received: February 27, 2013
Last updated: March 28, 2016
Last verified: March 2016
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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 |
Resource links provided by NLM:
Further study details as provided by Oregon Health and Science University:
Primary Outcome Measures:
- Combined death and serious cardiac events [ Time Frame: 30 days ] [ Designated as safety issue: No ]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:
- Non-cardiac serious events [ Time Frame: 30-days ] [ Designated as safety issue: No ]
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.
| Estimated Enrollment: | 3700 |
| Study Start Date: | April 2013 |
| Estimated Study Completion Date: | August 2016 |
| Estimated Primary Completion Date: | August 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) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Emergency Departments (ED)
Criteria
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 Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01802398
Please refer to this study by its ClinicalTrials.gov identifier: NCT01802398
Contacts
| Contact: Benjamin C Sun, MD | 503-494-1193 | sunb@ohsu.edu | |
| Contact: Marie-Annick N Yagapen, MPH, CCRP | yagapenm@ohsu.edu |
Locations
| United States, California | |
| University of California, Davis | UC Davis | Recruiting |
| Sacramento, California, United States, 95817 | |
| Contact: Daniel B Nishijima, MD daniel.nishijima@ucdmc.ucdavis.edu | |
| Contact: Toni Harbour, MPH, CCRC 916-734-8131 toni.harbour@ucdmc.ucdavis.edu | |
| Principal Investigator: Daniel Nishijima, MD | |
| United States, Massachusetts | |
| Brigham and Women's Hospital | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Christopher W Baugh, M.D.,M.B.A. CBAUGH@PARTNERS.ORG | |
| Contact: Sean C Hagan 617-732-5638 SCHAGAN@PARTNERS.ORG | |
| Principal Investigator: Christopher W Baugh, M.D.,M.B.A. | |
| United States, Michigan | |
| Beaumont Health System | Recruiting |
| Troy and Royal Oak, Michigan, United States, 48085 | |
| Contact: Carol Clark, MD Carol.Clark@beaumont.edu | |
| Contact: Pamela Marsack 248-964-6055 Pamela.Marsack@beaumont.edu | |
| Principal Investigator: Carol Clark, MD | |
| United States, New York | |
| URMC, Emergency Department | Recruiting |
| Rochester, New York, United States, 14642 | |
| Contact: David Adler, MD David_Adler@URMC.Rochester.edu | |
| Contact: Nancy Wood, MS 585.276.6565 nancy_wood@urmc.rochester.edu | |
| Principal Investigator: David Adler, MD | |
| United States, North Carolina | |
| Wakeforest, Department of Emergency Medicine | Recruiting |
| Winston-Salem, North Carolina, United States, 27157 | |
| Contact: Bret Nicks, MD bnicks@wfubmc.edu | |
| Contact: Brian Y Miller 336-716-2049 bymiller@wakehealth.edu | |
| Principal Investigator: Bret Nicks, MD | |
| United States, Ohio | |
| Summa Health System, Department of Emergency Medicine (Research) | Recruiting |
| Akron, Ohio, United States, 44304 | |
| Contact: Scott Wilber, MD wilbers@summahealth.org | |
| Contact: Jennifer Frey, PhD (330) 375-7530 freyja@summahealth.org | |
| Principal Investigator: Scott Wilber, MD | |
| Ohio State University | Recruiting |
| Columbus, Ohio, United States, 43210 | |
| Contact: Jeffrey Caterino, MD Jeffrey.Caterino@osumc.edu | |
| Contact: Leesha Bolton, CCRP 614.366.7554 leesha.bolton@osumc.edu | |
| Principal Investigator: Jeffrey Caterino, MD | |
| United States, Oregon | |
| Oregon Health and Science University | Recruiting |
| Portland, Oregon, United States, 97229 | |
| Contact: Benjamin C Sun, MD 503-494-1193 sunb@ohsu.edu | |
| Contact: Marie-Annick N Yagapen, MPH, CCRP 503-494-1104 yagapenm@ohsu.edu | |
| Principal Investigator: Benjamin C Sun, MD | |
| United States, Pennsylvania | |
| Thomas Jefferson University | Recruiting |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Contact: Judd Hollander, MD judd.hollander@jefferson.edu | |
| Contact: Nicole Renzi, RN 215-684-9391 Nicole.Renzi@jefferson.edu | |
| Principal Investigator: Judd Hollander, MD | |
| United States, Tennessee | |
| Vanderbilt University Medical Center | Recruiting |
| Nashville, Tennessee, United States, 327232-4700 | |
| Contact: Alan B Storrow, MD alan.b.storrow@Vanderbilt.Edu | |
| Contact: Kelly Moser, BS, CCRP 615-936-2651 Kelly.moser@vanderbilt.edu | |
| Principal Investigator: Alan B Storrow, MD | |
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
| 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: | March 28, 2016 |
| Health Authority: | United States: Office for Human Research Protections (OHRP). |
Keywords provided by 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 September 26, 2016