Improving Syncope Risk Stratification in Older Adults (SRS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01802398|
Recruitment Status : Completed
First Posted : March 1, 2013
Last Update Posted : April 4, 2017
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|
|Study Type :||Observational|
|Actual Enrollment :||3707 participants|
|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|
Observational cohort study of older (age≥60 years) adults who present to an emergency department with syncope (otherwise known as fainting)
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|