Prospective Study on Prognosis of Cardiac Resynchronized Therapy (CRT), Implantable Cardioverter Defibrillator (ICD) Implantation in Patients With Congestive Heart Failure (CHF)
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Voraussichtlich)
Kontakte und Standorte
Studienkontakt
- Name: Boyoung Joung, MD, PhD
- Telefonnummer: 82-2-2228-8460
- E-Mail: cby6908@yuhs.ac
Studienorte
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-
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Seoul, Korea, Republik von, 120-752
- Rekrutierung
- Severance Hospital
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Kontakt:
- Boyoung Joung, MD, PhD
- Telefonnummer: 82-2-2228-8460
- E-Mail: cby6908@yuhs.ac
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: Kohorte
- Zeitperspektiven: Interessent
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
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ICD/CRT registry
ICD / CRTregistry in Severance or Ewha Womans University Medical Center
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cardiac resynchronized therapy (CRT), implantable cardioverter defibrillator (ICD) implantation
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Transthoracic echocardiography (TTE)
Zeitfenster: before enrollment
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before enrollment
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Transthoracic echocardiography (TTE)
Zeitfenster: 12 month later afer enrollment
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12 month later afer enrollment
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EKG
Zeitfenster: before enrollment
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for Ventricular arrhythmia events
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before enrollment
|
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EKG
Zeitfenster: 1 month later after enrollment
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for Ventricular arrhythmia events
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1 month later after enrollment
|
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EKG
Zeitfenster: 6 month later after enrollment
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for Ventricular arrhythmia events
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6 month later after enrollment
|
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EKG
Zeitfenster: 12 month later after enrollment
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for Ventricular arrhythmia events
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12 month later after enrollment
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NYHA(New York Heart Association) evaluation
Zeitfenster: before enrollment
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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
|
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NYHA(New York Heart Association) evaluation
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
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6 minute walking test
Zeitfenster: before enrollment
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for functional capacity
|
before enrollment
|
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6 minute walking test
Zeitfenster: 12 month later afer enrollment
|
for functional capacity
|
12 month later afer enrollment
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Questionnaire on Quality of Life(QOL) : EQ-5D-3L (Optional)
Zeitfenster: 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).
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before enrollment
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Questionnaire on Quality of Life(QOL) : EQ-5D-3L (Optional)
Zeitfenster: 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
Zeitfenster: before enrollment
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before enrollment
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Cardiac MRI or Cardiac CT
Zeitfenster: 12 month later afer enrollment
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12 month later afer enrollment
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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 4-2014-0098
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