Improving Syncope Risk Stratification in Older Adults (SRS)
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.
|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 ] [ 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.
- 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.
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||January 2016|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
Observational cohort study of older (age≥60 years) adults who present to an emergency department with syncope (otherwise known as fainting)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01802398
|Contact: Benjamin C Sun, MDfirstname.lastname@example.org|
|United States, California|
|University of California, Davis | UC Davis||Recruiting|
|Sacramento, California, United States, 95817|
|Contact: Daniel B Nishijima, MD email@example.com|
|Contact: Toni Harbour, MPH, CCRC 916-734-8131 firstname.lastname@example.org|
|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: Thomas Kuczmarski 617-732-5638 email@example.com|
|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: Manish Shah, MD firstname.lastname@example.org|
|Contact: Nancy Wood, MS 585.276.6565 email@example.com|
|Principal Investigator: Manish Shah, MD|
|United States, North Carolina|
|Wakeforest, Department of Emergency Medicine||Recruiting|
|Winston-Salem, North Carolina, United States, 27157|
|Contact: Bret Nicks, MD firstname.lastname@example.org|
|Contact: Erin C McLean 336-716-2049 email@example.com|
|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 firstname.lastname@example.org|
|Contact: Jennifer Frey, PhD (330) 375-7530 email@example.com|
|Principal Investigator: Scott Wilber, MD|
|Ohio State University||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Jeffrey Caterino, MD Jeffrey.Caterino@osumc.edu|
|Contact: Heidi E Gehring, CCRP 614.366.7554 Heidi.Gehring@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 firstname.lastname@example.org|
|Contact: Marie-Annick N Yagapen, MPH, CCRP 503-494-1104 email@example.com|
|Principal Investigator: Benjamin C Sun, MD|
|United States, Pennsylvania|
|Thomas Jefferson University||Recruiting|
|Philadelphia, Pennsylvania, United States, 19107|
|Contact: Judd Hollander, MD firstname.lastname@example.org|
|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.email@example.com|
|Principal Investigator: Alan B Storrow, MD|
|Principal Investigator:||Benjamin C Sun, MD||Oregon Health and Science University|