Prospective Study on Prognosis of Cardiac Resynchronized Therapy (CRT), Implantable Cardioverter Defibrillator (ICD) Implantation in Patients With Congestive Heart Failure (CHF)
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Antecipado)
Contactos e Locais
Contato de estudo
- Nome: Boyoung Joung, MD, PhD
- Número de telefone: 82-2-2228-8460
- E-mail: cby6908@yuhs.ac
Locais de estudo
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Seoul, Republica da Coréia, 120-752
- Recrutamento
- Severance Hospital
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Contato:
- Boyoung Joung, MD, PhD
- Número de telefone: 82-2-2228-8460
- E-mail: cby6908@yuhs.ac
-
-
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 >=18
- LV ejection fraction <40% or Clinical HF Symptom with (LV ejection fraction >40%)
- medication for at least 3month
Exclusion Criteria:
1. patient who refuse to enroll the study
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Coorte
- Perspectivas de Tempo: Prospectivo
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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ICD/CRT registry
ICD / CRTregistry in Severance or Ewha Womans University Medical Center
|
cardiac resynchronized therapy (CRT), implantable cardioverter defibrillator (ICD) implantation
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Transthoracic echocardiography (TTE)
Prazo: before enrollment
|
before enrollment
|
|
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Transthoracic echocardiography (TTE)
Prazo: 12 month later afer enrollment
|
12 month later afer enrollment
|
|
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EKG
Prazo: before enrollment
|
for Ventricular arrhythmia events
|
before enrollment
|
|
EKG
Prazo: 1 month later after enrollment
|
for Ventricular arrhythmia events
|
1 month later after enrollment
|
|
EKG
Prazo: 6 month later after enrollment
|
for Ventricular arrhythmia events
|
6 month later after enrollment
|
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EKG
Prazo: 12 month later after enrollment
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for Ventricular arrhythmia events
|
12 month later after enrollment
|
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NYHA(New York Heart Association) evaluation
Prazo: before enrollment
|
For functional capacity - The New York Heart Association (NYHA) Functional Classification provides a simple way of classifying the extent of heart failure. It places patients in one of four categories based on how much they are limited during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina. |
before enrollment
|
|
NYHA(New York Heart Association) evaluation
Prazo: 1 month later after enrollment
|
For functional capacity - The New York Heart Association (NYHA) Functional Classification provides a simple way of classifying the extent of heart failure. It places patients in one of four categories based on how much they are limited during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina. |
1 month later after enrollment
|
|
NYHA(New York Heart Association) evaluation
Prazo: 6 month later after enrollment
|
For functional capacity - The New York Heart Association (NYHA) Functional Classification provides a simple way of classifying the extent of heart failure. It places patients in one of four categories based on how much they are limited during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina. |
6 month later after enrollment
|
|
NYHA(New York Heart Association) evaluation
Prazo: 12 month later after enrollment
|
For functional capacity - The New York Heart Association (NYHA) Functional Classification provides a simple way of classifying the extent of heart failure. It places patients in one of four categories based on how much they are limited during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina. |
12 month later after enrollment
|
|
6 minute walking test
Prazo: before enrollment
|
for functional capacity
|
before enrollment
|
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6 minute walking test
Prazo: 12 month later afer enrollment
|
for functional capacity
|
12 month later afer enrollment
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Questionnaire on Quality of Life(QOL) : EQ-5D-3L (Optional)
Prazo: before enrollment
|
EQ-5D-3L is the scale used in the health state description part was three-level; having no problems, having some or moderate problems, being unable to do/having extreme problems.
Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3.
As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 33333 (having extreme problems in all dimensions).
|
before enrollment
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Questionnaire on Quality of Life(QOL) : EQ-5D-3L (Optional)
Prazo: 12 month later afer enrollment
|
EQ-5D-3L is the scale used in the health state description part was three-level; having no problems, having some or moderate problems, being unable to do/having extreme problems.
Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3.
As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 33333 (having extreme problems in all dimensions).
|
12 month later afer enrollment
|
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Cardiac MRI or Cardiac CT
Prazo: before enrollment
|
before enrollment
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Cardiac MRI or Cardiac CT
Prazo: 12 month later afer enrollment
|
12 month later afer enrollment
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
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
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 4-2014-0098
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