Prospective Study on Prognosis of Cardiac Resynchronized Therapy (CRT), Implantable Cardioverter Defibrillator (ICD) Implantation in Patients With Congestive Heart Failure (CHF)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Boyoung Joung, MD, PhD
- Numéro de téléphone: 82-2-2228-8460
- E-mail: cby6908@yuhs.ac
Lieux d'étude
-
-
-
Seoul, Corée, République de, 120-752
- Recrutement
- Severance Hospital
-
Contact:
- Boyoung Joung, MD, PhD
- Numéro de téléphone: 82-2-2228-8460
- E-mail: cby6908@yuhs.ac
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cohorte
- Perspectives temporelles: Éventuel
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
ICD/CRT registry
ICD / CRTregistry in Severance or Ewha Womans University Medical Center
|
cardiac resynchronized therapy (CRT), implantable cardioverter defibrillator (ICD) implantation
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Transthoracic echocardiography (TTE)
Délai: before enrollment
|
before enrollment
|
|
|
Transthoracic echocardiography (TTE)
Délai: 12 month later afer enrollment
|
12 month later afer enrollment
|
|
|
EKG
Délai: before enrollment
|
for Ventricular arrhythmia events
|
before enrollment
|
|
EKG
Délai: 1 month later after enrollment
|
for Ventricular arrhythmia events
|
1 month later after enrollment
|
|
EKG
Délai: 6 month later after enrollment
|
for Ventricular arrhythmia events
|
6 month later after enrollment
|
|
EKG
Délai: 12 month later after enrollment
|
for Ventricular arrhythmia events
|
12 month later after enrollment
|
|
NYHA(New York Heart Association) evaluation
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: before enrollment
|
for functional capacity
|
before enrollment
|
|
6 minute walking test
Délai: 12 month later afer enrollment
|
for functional capacity
|
12 month later afer enrollment
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Questionnaire on Quality of Life(QOL) : EQ-5D-3L (Optional)
Délai: 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
|
|
Questionnaire on Quality of Life(QOL) : EQ-5D-3L (Optional)
Délai: 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
|
|
Cardiac MRI or Cardiac CT
Délai: before enrollment
|
before enrollment
|
|
|
Cardiac MRI or Cardiac CT
Délai: 12 month later afer enrollment
|
12 month later afer enrollment
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 4-2014-0098
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .