- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02139449
Prospective Study on Prognosis of Cardiac Resynchronized Therapy (CRT), Implantable Cardioverter Defibrillator (ICD) Implantation in Patients With Congestive Heart Failure (CHF)
연구 개요
연구 유형
등록 (예상)
연락처 및 위치
연구 연락처
- 이름: Boyoung Joung, MD, PhD
- 전화번호: 82-2-2228-8460
- 이메일: cby6908@yuhs.ac
연구 장소
-
-
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Seoul, 대한민국, 120-752
- 모병
- Severance Hospital
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연락하다:
- Boyoung Joung, MD, PhD
- 전화번호: 82-2-2228-8460
- 이메일: cby6908@yuhs.ac
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 보병대
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
ICD/CRT registry
ICD / CRTregistry in Severance or Ewha Womans University Medical Center
|
cardiac resynchronized therapy (CRT), implantable cardioverter defibrillator (ICD) implantation
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Transthoracic echocardiography (TTE)
기간: before enrollment
|
before enrollment
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Transthoracic echocardiography (TTE)
기간: 12 month later afer enrollment
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12 month later afer enrollment
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|
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EKG
기간: before enrollment
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for Ventricular arrhythmia events
|
before enrollment
|
|
EKG
기간: 1 month later after enrollment
|
for Ventricular arrhythmia events
|
1 month later after enrollment
|
|
EKG
기간: 6 month later after enrollment
|
for Ventricular arrhythmia events
|
6 month later after enrollment
|
|
EKG
기간: 12 month later after enrollment
|
for Ventricular arrhythmia events
|
12 month later after enrollment
|
|
NYHA(New York Heart Association) evaluation
기간: 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
기간: 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
기간: 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
기간: 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
기간: before enrollment
|
for functional capacity
|
before enrollment
|
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6 minute walking test
기간: 12 month later afer enrollment
|
for functional capacity
|
12 month later afer enrollment
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Questionnaire on Quality of Life(QOL) : EQ-5D-3L (Optional)
기간: 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)
기간: 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
기간: before enrollment
|
before enrollment
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Cardiac MRI or Cardiac CT
기간: 12 month later afer enrollment
|
12 month later afer enrollment
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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