Statin for Depression in Patients Undergoing Coronary Artery Bypass Graft (Stress CABG)

This study is currently recruiting participants.
Verified May 2012 by China National Center for Cardiovascular Diseases
Sponsor:
Information provided by (Responsible Party):
China National Center for Cardiovascular Diseases
ClinicalTrials.gov Identifier:
NCT01624857
First received: June 17, 2012
Last updated: August 13, 2013
Last verified: May 2012

June 17, 2012
August 13, 2013
June 2012
December 2013   (final data collection date for primary outcome measure)
  • Depression [ Time Frame: 1 month after surgery ] [ Designated as safety issue: Yes ]
    The Hamilton Depression Rating Scale (HDRS) scores
  • General health status [ Time Frame: 1 month after surgery ] [ Designated as safety issue: Yes ]
    36-Item Short-From Health Survey (SF-36) scores
Same as current
Complete list of historical versions of study NCT01624857 on ClinicalTrials.gov Archive Site
MACE [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
Composite of major adverse cardiac events (MACE) including death, myocardial infarction and/or revascularization
Same as current
Not Provided
Not Provided
 
Statin for Depression in Patients Undergoing Coronary Artery Bypass Graft
Perioperative Statin for Depression in Patients Undergoing Coronary Artery Bypass Surgery

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Coronary Heart Disease
  • Drug: Rosuvastatin
    Rosuvastatin for at least 5 days before the CABG surgery, then continue to take for a month after the surgery.
  • Drug: Placebo
    Placebo for at least 5 days before the CABG surgery, then continue to take for a month after the surgery.
  • Placebo Comparator: control group
    Placebo for at least 5 days before the CABG surgery, then continue to take for a month after the surgery.
    Intervention: Drug: Placebo
  • Active Comparator: statin group
    Rosuvastatin 20mg/d for at least 5 days before the CABG surgery, then continue to take for a month
    Intervention: Drug: Rosuvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
June 2014
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Hospitalized patients for coronary artery bypass graft surgery

Exclusion Criteria:

  • Previous CABG surgery
Both
18 Years and older
No
Contact: Zhe Zheng, M.D., Ph.D. 8610-88396051 zhengzhefuwai@tom.com
China
 
NCT01624857
20120618
Yes
China National Center for Cardiovascular Diseases
China National Center for Cardiovascular Diseases
Not Provided
Principal Investigator: Zhe Zheng, M.D., Ph.D. China National Center for Cardiovascular Diseases
China National Center for Cardiovascular Diseases
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP