Prospective Study on Prognosis of Cardiac Resynchronized Therapy (CRT), Implantable Cardioverter Defibrillator (ICD) Implantation in Patients With Congestive Heart Failure (CHF)
調査の概要
研究の種類
入学 (予想される)
連絡先と場所
研究連絡先
- 名前：Boyoung Joung, MD, PhD
- 電話番号：82-2-2228-8460
- メール：cby6908@yuhs.ac
研究場所
-
-
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Seoul、大韓民国、120-752
- 募集
- Severance Hospital
-
コンタクト：
- Boyoung Joung, MD, PhD
- 電話番号：82-2-2228-8460
- メール：cby6908@yuhs.ac
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：コホート
- 時間の展望：見込みのある
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
ICD/CRT registry
ICD / CRTregistry in Severance or Ewha Womans University Medical Center
|
cardiac resynchronized therapy (CRT), implantable cardioverter defibrillator (ICD) implantation
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Transthoracic echocardiography (TTE)
時間枠：before enrollment
|
before enrollment
|
|
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Transthoracic echocardiography (TTE)
時間枠：12 month later afer enrollment
|
12 month later afer enrollment
|
|
|
EKG
時間枠：before enrollment
|
for Ventricular arrhythmia events
|
before enrollment
|
|
EKG
時間枠：1 month later after enrollment
|
for Ventricular arrhythmia events
|
1 month later after enrollment
|
|
EKG
時間枠：6 month later after enrollment
|
for Ventricular arrhythmia events
|
6 month later after enrollment
|
|
EKG
時間枠：12 month later after enrollment
|
for Ventricular arrhythmia events
|
12 month later after enrollment
|
|
NYHA(New York Heart Association) evaluation
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：before enrollment
|
for functional capacity
|
before enrollment
|
|
6 minute walking test
時間枠：12 month later afer enrollment
|
for functional capacity
|
12 month later afer enrollment
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Questionnaire on Quality of Life(QOL) : EQ-5D-3L (Optional)
時間枠：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)
時間枠：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
時間枠：before enrollment
|
before enrollment
|
|
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Cardiac MRI or Cardiac CT
時間枠：12 month later afer enrollment
|
12 month later afer enrollment
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。