跳至主要内容
临床试验/NCT01624857
NCT01624857Unknown3 期

Perioperative Statin for Depression in Patients Undergoing Coronary Artery Bypass Surgery

China National Center for Cardiovascular Diseases1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2012年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
发起方
入组人数
400
试验地点
1
主要终点
Depression

研究概览

简要总结

Depression is frequently observed in patients with coronary heart disease (CHD) and represents a significant risk factor for major cardiovascular events. Previous study has proved that high sensitive C-reactive protein (hsCRP) was an independent predictor for depression in CABG patients at 6 months after bypass surgery. Statins can effectively reduce the blood levels of hsCRP. This study aim to examine whether statins can improve the prognosis of depressive patients undergoing coronary artery bypass surgery through reducing the levels of hsCRP.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hospitalized patients for coronary artery bypass graft surgery

排除标准

  • Previous CABG surgery

研究组 & 干预措施

control group

Placebo Comparator

Placebo for at least 5 days before the CABG surgery, then continue to take for a month after the surgery.

干预措施: Placebo (Drug)

statin group

Active Comparator

Rosuvastatin 20mg/d for at least 5 days before the CABG surgery, then continue to take for a month

干预措施: Rosuvastatin (Drug)

结局指标

主要结局

Depression

时间窗: 1 month after surgery

The Hamilton Depression Rating Scale (HDRS) scores

General health status

时间窗: 1 month after surgery

36-Item Short-From Health Survey (SF-36) scores

次要结局

  • MACE(6 month)

研究者

发起方
China National Center for Cardiovascular Diseases
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验