- 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
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-
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
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cardiac resynchronized therapy (CRT), implantable cardioverter defibrillator (ICD) implantation
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Transthoracic echocardiography (TTE)
기간: before enrollment
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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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EKG
기간: before enrollment
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for Ventricular arrhythmia events
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before enrollment
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EKG
기간: 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
기간: 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
기간: 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
기간: 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
기간: 1 month later after 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. |
1 month later after enrollment
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NYHA(New York Heart Association) evaluation
기간: 6 month later after 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. |
6 month later after enrollment
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NYHA(New York Heart Association) evaluation
기간: 12 month later after 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. |
12 month later after enrollment
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6 minute walking test
기간: before enrollment
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for functional capacity
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before enrollment
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6 minute walking test
기간: 12 month later afer enrollment
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for functional capacity
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12 month later afer enrollment
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Questionnaire on Quality of Life(QOL) : EQ-5D-3L (Optional)
기간: before enrollment
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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)
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).
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12 month later afer enrollment
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Cardiac MRI or Cardiac CT
기간: before enrollment
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before enrollment
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Cardiac MRI or Cardiac CT
기간: 12 month later afer enrollment
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12 month later afer enrollment
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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
이 연구와 관련된 용어
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
울혈 성 심부전증에 대한 임상 시험
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Medical University of BialystokInstitute of Cardiology, Warsaw, Poland; Medical University of Lodz; Poznan University of... 그리고 다른 협력자들아직 모집하지 않음심부전, 수축기 | 박출률이 감소된 심부전 | 심부전 New York Heart Association Class IV | 심부전 New York Heart Association Class III폴란드
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Novartis Pharmaceuticals완전한핵심 연구의 12개월 치료 기간을 성공적으로 완료한 환자(de Novo Heart Recipients)는 EC-MPS 치료에 관심이 있었습니다.
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University of WashingtonAmerican Heart Association완전한심부전,울혈 | 미토콘드리아 변경 | 심부전 New York Heart Association Class IV미국
ICD/CRT에 대한 임상 시험
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Boston Scientific CorporationICON Clinical Research완전한
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Prof. Dr. med. Ingo EitelDeutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)모병
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Medtronic Cardiac Rhythm and Heart Failure완전한심부전 | 심실 기능 장애 | 부정맥미국, 네덜란드, 콜롬비아, 남아프리카, 일본, 이스라엘, 스페인, 캐나다, 영국, 독일, 슬로베니아, 스웨덴, 사우디 아라비아, 스위스, 말레이시아, 오스트리아, 체코, 덴마크, 인도, 이탈리아, 아랍 에미리트
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Ottawa Heart Institute Research CorporationCanadian Institutes of Health Research (CIHR)모집하지 않고 적극적으로
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Ottawa Heart Institute Research CorporationCanadian Institutes of Health Research (CIHR); Medtronic완전한
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Medtronic Cardiac Rhythm and Heart Failure완전한심실 부정맥 | 급성 심정지중국, 대한민국, 대만, 아르헨티나, 콜롬비아, 싱가포르, 러시아 연방, 인도, 남아프리카, 말레이시아, 아랍 에미리트, 벨라루스, 브라질, 이집트, 멕시코, 튀니지