- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01624857
Statin for Depression in Patients Undergoing Coronary Artery Bypass Graft (Stress CABG)
Perioperative Statin for Depression in Patients Undergoing Coronary Artery Bypass Surgery
연구 개요
상세 설명
Depression is frequently observed in patients with coronary heart disease (CHD) and represents a significant risk factor for major cardiovascular events. Depression in patients with existing CHD confers a relative risk between 1.5 and 2.5 for cardiac morbidity and mortality. In previous cross-sectional and prospective studies, the prevalence of major depression in patients with CHD ranged from 10% to 47%, and slightly higher rates were reported (28%) in patients requiring coronary artery bypass grafting (CABG). In CABG patients, symptoms of depression may increase mortality after bypass surgery and were associated with atherosclerotic progression.
In 2008, the American Heart Association recommended routine screening for depression in patients with CHD in various settings, including the hospital, physician's office, clinic, and cardiac rehabilitation center. In recent years, growing evidence also suggests the existence of a bidirectional relationship between depressed mood and inflammation. Dantzer and associates reported that inflammation can lead to the development of symptoms of depression in vulnerable individuals. Consistent with these findings, high-sensitivity C-reactive protein (hsCRP), currently as one available clinical biomarker of inflammation, was reported associated with increased long-term mortality and extended hospital length of stay in patients undergoing nonemergency CABG-only surgery. And our previous study showed that elevated serum hsCRP is an independent predictor for depression in CABG patients not only preoperatively but also up to 6 months after surgery.
This study will enroll patients undergoing coronary artery bypass surgery in Fuwai Hospital. At study entry, participants will be interviewed during their index hospitalization, to collect information about depressive symptoms, functioning, quality of life, and medical care. Demographic characteristics, medical history, clinical features, diagnostic tests, medications, procedures, and in-hospital outcomes of patients will be abstracted from medical records by well trained professional abstractors. At 1 month and 6 month after discharge, participants will return to the clinic for follow up visits, a face-to-face interview will be conducted to get information about clinical events, depressive symptoms, functioning, quality of life, and medical care during the recovery period. Practical guidelines will be established based on the findings to improve patients' outcomes in future finally.
연구 유형
등록 (예상)
단계
- 3단계
연락처 및 위치
연구 장소
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Beijing
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Beijing, Beijing, 중국, 100037
- 모병
- China National Center for Cardiovascular Diseases
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Hospitalized patients for coronary artery bypass graft surgery
Exclusion Criteria:
- Previous CABG surgery
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
위약 비교기: control group
Placebo for at least 5 days before the CABG surgery, then continue to take for a month after the surgery.
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Placebo for at least 5 days before the CABG surgery, then continue to take for a month after the surgery.
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활성 비교기: statin group
Rosuvastatin 20mg/d for at least 5 days before the CABG surgery, then continue to take for a month
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Rosuvastatin for at least 5 days before the CABG surgery, then continue to take for a month after the surgery.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Depression
기간: 1 month after surgery
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The Hamilton Depression Rating Scale (HDRS) scores
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1 month after surgery
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General health status
기간: 1 month after surgery
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36-Item Short-From Health Survey (SF-36) scores
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1 month after surgery
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
MACE
기간: 6 month
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Composite of major adverse cardiac events (MACE) including death, myocardial infarction and/or revascularization
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6 month
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공동 작업자 및 조사자
수사관
- 수석 연구원: Zhe Zheng, M.D., Ph.D., China National Center for Cardiovascular Diseases
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 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .
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Placebo에 대한 임상 시험
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Assistance Publique - Hôpitaux de Paris아직 모집하지 않음
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University Hospital, Strasbourg, France모집하지 않고 적극적으로
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AJU Pharm Co., Ltd.OM Pharma SA모병