Improving Syncope Risk Stratification in Older Adults

NCT01802398 | Completed

• 1 other identifier: NIH R01 HL111033-01A1
• Study Type: observational
• Target: 3,707
• Locations: 1 country
• Sites: 10

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.

Conditions

Syncope

Keywords

Risk Stratification; Syncope; Geriatric

Outcome Measures

Primary Outcomes (1)

• Combined death and serious cardiac events

  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.

  30 days

Other Outcomes (1)

• Non-cardiac serious events

  30-days

Study Arms (1)

No treatment

Observational cohort study of older (age≥60 years) adults who present to an emergency department with syncope (otherwise known as fainting)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Emergency Departments (ED)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institutes of Health (NIH): collaborator

Study Sites (10)

University of California, Davis | UC Davis

Sacramento, California, 95817, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Beaumont Health System

Royal Oak, Michigan, 48085, United States

Location

URMC, Emergency Department

Rochester, New York, 14642, United States

Location

Wakeforest, Department of Emergency Medicine

Winston-Salem, North Carolina, 27157, United States

Location

Summa Health System, Department of Emergency Medicine (Research)

Akron, Ohio, 44304, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Oregon Health and Science University

Portland, Oregon, 97229, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 327232-4700, United States

Location

Related Publications (9)

• Zimmermann T, du Fay de Lavallaz J, Walter JE, Strebel I, Nestelberger T, Joray L, Badertscher P, Flores D, Widmer V, Geigy N, Miro O, Salgado E, Christ M, Cullen L, Than M, Martin-Sanchez FJ, Di Somma S, Peacock WF, Keller D, Costabel JP, Wussler DN, Kawecki D, Lohrmann J, Gualandro DM, Kuehne M, Reichlin T, Sun B, Mueller C; BASEL IX and SRS Investigators. Development of an electrocardiogram-based risk calculator for a cardiac cause of syncope. Heart. 2021 Nov;107(22):1796-1804. doi: 10.1136/heartjnl-2020-318430. Epub 2021 Jan 27.

  PMID: 33504514 DERIVED

• Probst MA, Gibson T, Weiss RE, Yagapen AN, Malveau SE, Adler DH, Bastani A, Baugh CW, Caterino JM, Clark CL, Diercks DB, Hollander JE, Nicks BA, Nishijima DK, Shah MN, Stiffler KA, Storrow AB, Wilber ST, Sun BC. Risk Stratification of Older Adults Who Present to the Emergency Department With Syncope: The FAINT Score. Ann Emerg Med. 2020 Feb;75(2):147-158. doi: 10.1016/j.annemergmed.2019.08.429. Epub 2019 Oct 23.

  PMID: 31668571 DERIVED

• Probst MA, Su E, Weiss RE, Yagapen AN, Malveau SE, Adler DH, Bastani A, Baugh CW, Caterino JM, Clark CL, Diercks DB, Hollander JE, Nicks BA, Nishijima DK, Shah MN, Stiffler KA, Storrow AB, Wilber ST, Sun BC. Clinical Benefit of Hospitalization for Older Adults With Unexplained Syncope: A Propensity-Matched Analysis. Ann Emerg Med. 2019 Aug;74(2):260-269. doi: 10.1016/j.annemergmed.2019.03.031. Epub 2019 May 9.

  PMID: 31080027 DERIVED

• Clark CL, Gibson TA, Weiss RE, Yagapen AN, Malveau SE, Adler DH, Bastani A, Baugh CW, Caterino JM, Diercks DB, Hollander JE, Nicks BA, Nishijima DK, Shah MN, Stiffler KA, Storrow AB, Wilber ST, Sun BC. Do High-sensitivity Troponin and Natriuretic Peptide Predict Death or Serious Cardiac Outcomes After Syncope? Acad Emerg Med. 2019 May;26(5):528-538. doi: 10.1111/acem.13709. Epub 2019 Mar 4.

  PMID: 30721554 DERIVED

• Thiruganasambandamoorthy V, Sivilotti MLA, Rowe BH, McRae AD, Mukarram M, Malveau S, Yagapen AN, Sun BC; North American Syncope Consortium. Prevalence of Pulmonary Embolism Among Emergency Department Patients With Syncope: A Multicenter Prospective Cohort Study. Ann Emerg Med. 2019 May;73(5):500-510. doi: 10.1016/j.annemergmed.2018.12.005. Epub 2019 Jan 26.

  PMID: 30691921 DERIVED

• Bastani A, Su E, Adler DH, Baugh C, Caterino JM, Clark CL, Diercks DB, Hollander JE, Malveau SE, Nicks BA, Nishijima DK, Shah MN, Stiffler KA, Storrow AB, Wilber ST, Yagapen AN, Weiss RE, Sun BC. Comparison of 30-Day Serious Adverse Clinical Events for Elderly Patients Presenting to the Emergency Department With Near-Syncope Versus Syncope. Ann Emerg Med. 2019 Mar;73(3):274-280. doi: 10.1016/j.annemergmed.2018.10.032. Epub 2018 Dec 7.

  PMID: 30529112 DERIVED

• Chang AM, Hollander JE, Su E, Weiss RE, Yagapen AN, Malveau SE, Adler DH, Bastani A, Baugh CW, Caterino JM, Clark CL, Diercks DB, Nicks BA, Nishijima DK, Shah MN, Stiffler KA, Storrow AB, Wilber ST, Sun BC. Recurrent syncope is not an independent risk predictor for future syncopal events or adverse outcomes. Am J Emerg Med. 2019 May;37(5):869-872. doi: 10.1016/j.ajem.2018.08.004. Epub 2018 Aug 24.

  PMID: 30361153 DERIVED

• Probst MA, Gibson TA, Weiss RE, Yagapen AN, Malveau SE, Adler DH, Bastani A, Baugh CW, Caterino JM, Clark CL, Diercks DB, Hollander JE, Nicks BA, Nishijima DK, Shah MN, Stiffler KA, Storrow AB, Wilber ST, Sun BC. Predictors of Clinically Significant Echocardiography Findings in Older Adults with Syncope: A Secondary Analysis. J Hosp Med. 2018 Dec 1;13(12):823-828. doi: 10.12788/jhm.3082. Epub 2018 Sep 26.

  PMID: 30255862 DERIVED

• Nishijima DK, Lin AL, Weiss RE, Yagapen AN, Malveau SE, Adler DH, Bastani A, Baugh CW, Caterino JM, Clark CL, Diercks DB, Hollander JE, Nicks BA, Shah MN, Stiffler KA, Storrow AB, Wilber ST, Sun BC. ECG Predictors of Cardiac Arrhythmias in Older Adults With Syncope. Ann Emerg Med. 2018 Apr;71(4):452-461.e3. doi: 10.1016/j.annemergmed.2017.11.014. Epub 2017 Dec 21.

  PMID: 29275946 DERIVED

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.

MeSH Terms

Conditions

Syncope

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Benjamin C Sun, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Emergency Medicine

Study Record Dates

• First Submitted: February 27, 2013
• First Posted: March 1, 2013
• Study Start: April 1, 2013
• Primary Completion: September 21, 2016
• Study Completion: December 14, 2016
• Last Updated: January 24, 2019

Record last verified: 2019-01

Locations

US (10)