Improving Syncope Risk Stratification in Older Adults (SRS)
22. januar 2019 oppdatert av: Benjamin Sun, M.D., University of Pennsylvania
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.
Studieoversikt
Status
Fullført
Forhold
Studietype
Observasjonsmessig
Registrering (Faktiske)
3707
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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California
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Sacramento, California, Forente stater, 95817
- University of California, Davis | UC Davis
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Massachusetts
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Boston, Massachusetts, Forente stater, 02115
- Brigham and Women's Hospital
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Michigan
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Royal Oak, Michigan, Forente stater, 48085
- Beaumont Health System
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New York
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Rochester, New York, Forente stater, 14642
- URMC, Emergency Department
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North Carolina
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Winston-Salem, North Carolina, Forente stater, 27157
- Wakeforest, Department of Emergency Medicine
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Ohio
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Akron, Ohio, Forente stater, 44304
- Summa Health System, Department of Emergency Medicine (Research)
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Columbus, Ohio, Forente stater, 43210
- Ohio State University
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Oregon
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Portland, Oregon, Forente stater, 97229
- Oregon Health and Science University
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19107
- Thomas Jefferson University
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Tennessee
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Nashville, Tennessee, Forente stater, 327232-4700
- Vanderbilt University Medical Center
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
60 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Emergency Departments (ED)
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
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No treatment
Observational cohort study of older (age≥60 years) adults who present to an emergency department with syncope (otherwise known as fainting)
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Combined death and serious cardiac events
Tidsramme: 30 days
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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.
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30 days
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Andre resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Non-cardiac serious events
Tidsramme: 30-days
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30-days
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Benjamin C Sun, MD, Oregon Health and Science University
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. april 2013
Primær fullføring (Faktiske)
21. september 2016
Studiet fullført (Faktiske)
14. desember 2016
Datoer for studieregistrering
Først innsendt
27. februar 2013
Først innsendt som oppfylte QC-kriteriene
27. februar 2013
Først lagt ut (Anslag)
1. mars 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
24. januar 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
22. januar 2019
Sist bekreftet
1. januar 2019
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NIH R01 HL111033-01A1
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .