Statin for Depression in Patients Undergoing Coronary Artery Bypass Graft

Coronary Heart Disease Clinical Trial

— Stress CABG  

Official title:

Perioperative Statin for Depression in Patients Undergoing Coronary Artery Bypass Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01624857
• Other study ID #: 20120618
• Status: Recruiting
• Phase: Phase 3
• First received: June 17, 2012
• Last updated: August 13, 2013
• Start date: June 2012
• Est. completion date: June 2014

Study information

• Verified date: May 2012
• Source: China National Center for Cardiovascular Diseases
• Contact: Zhe Zheng, M.D., Ph.D.
• Phone: 8610-88396051
• Email: zhengzhefuwai[@]tom.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Hospitalized patients for coronary artery bypass graft surgery

Exclusion Criteria:

• Previous CABG surgery

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
China	China National Center for Cardiovascular Diseases	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression	The Hamilton Depression Rating Scale (HDRS) scores	1 month after surgery	Yes
Primary	General health status	36-Item Short-From Health Survey (SF-36) scores	1 month after surgery	Yes
Secondary	MACE	Composite of major adverse cardiac events (MACE) including death, myocardial infarction and/or revascularization	6 month	Yes