Statin for Depression in Patients Undergoing Coronary Artery Bypass Graft (Stress CABG)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Heart Disease |
Drug: Rosuvastatin Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Perioperative Statin for Depression in Patients Undergoing Coronary Artery Bypass Surgery |
- 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
- MACE [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]Composite of major adverse cardiac events (MACE) including death, myocardial infarction and/or revascularization
| Estimated Enrollment: | 400 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: control group
Placebo 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.
|
|
Active Comparator: statin group
Rosuvastatin 20mg/d for at least 5 days before the CABG surgery, then continue to take for a month
|
Drug: Rosuvastatin
Rosuvastatin for at least 5 days before the CABG surgery, then continue to take for a month after the surgery.
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Hospitalized patients for coronary artery bypass graft surgery
Exclusion Criteria:
- Previous CABG surgery
Contacts and Locations| Contact: Zhe Zheng, M.D., Ph.D. | 8610-88396051 | zhengzhefuwai@tom.com |
| China, Beijing | |
| China National Center for Cardiovascular Diseases | Recruiting |
| Beijing, Beijing, China, 100037 | |
| Contact: Zhe Zheng, M.D., Ph.D. 8610-8839-6051 zhengzhefuwai@tom.com | |
| Principal Investigator: Zhe Zheng, M.D., Ph.D. | |
| Principal Investigator: | Zhe Zheng, M.D., Ph.D. | China National Center for Cardiovascular Diseases |
More Information
No publications provided
| Responsible Party: | China National Center for Cardiovascular Diseases |
| ClinicalTrials.gov Identifier: | NCT01624857 History of Changes |
| Other Study ID Numbers: | 20120618 |
| Study First Received: | June 17, 2012 |
| Last Updated: | July 12, 2012 |
| Health Authority: | China: Ministry of Health |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Depression Depressive Disorder Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Behavioral Symptoms Mood Disorders |
Mental Disorders Rosuvastatin Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013