- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01802398
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.
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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California
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Sacramento, California, Estados Unidos, 95817
- University of California, Davis | UC Davis
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02115
- Brigham and Women's Hospital
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Michigan
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Royal Oak, Michigan, Estados Unidos, 48085
- Beaumont Health System
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New York
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Rochester, New York, Estados Unidos, 14642
- URMC, Emergency Department
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North Carolina
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Winston-Salem, North Carolina, Estados Unidos, 27157
- Wakeforest, Department of Emergency Medicine
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Ohio
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Akron, Ohio, Estados Unidos, 44304
- Summa Health System, Department of Emergency Medicine (Research)
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Columbus, Ohio, Estados Unidos, 43210
- Ohio State University
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Oregon
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Portland, Oregon, Estados Unidos, 97229
- Oregon Health and Science University
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19107
- Thomas Jefferson University
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Tennessee
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Nashville, Tennessee, Estados Unidos, 327232-4700
- Vanderbilt University Medical Center
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Combined death and serious cardiac events
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Prazo |
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Non-cardiac serious events
Prazo: 30-days
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30-days
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Benjamin C Sun, MD, Oregon Health and Science University
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
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Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- NIH R01 HL111033-01A1
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