Clinical trial NCT01624857: Statin for Depression in Patients Undergoing Coronary Artery Bypass Graft
Official title: Perioperative Statin for Depression in Patients Undergoing Coronary Artery Bypass Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Coronary Heart Disease
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2012-06-21
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Hospitalized patients for coronary artery bypass graft surgery

Exclusion Criteria:

* Previous CABG surgery

Primary outcomes:
measure: Depression
timeFrame: 1 month after surgery
measure: General health status
timeFrame: 1 month after surgery
Secondary outcomes:
measure: MACE
timeFrame: 6 month
Other outcomes:
Locations:
city: Beijing
country: China
facility: China National Center for Cardiovascular Diseases
state: Beijing
Study officials:
affiliation: China National Center for Cardiovascular Diseases
name: Zhe Zheng, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: