Statin for Depression in Patients Undergoing Coronary Artery Bypass Graft
NCT ID: NCT01624857
Last Updated: 2013-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
400 participants
INTERVENTIONAL
2012-06-30
2014-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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control group
Placebo 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.
statin group
Rosuvastatin 20mg/d for at least 5 days before the CABG surgery, then continue to take for a month
Rosuvastatin
Rosuvastatin for at least 5 days before the CABG surgery, then continue to take for a month after the surgery.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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China National Center for Cardiovascular Diseases
OTHER_GOV
Responsible Party
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Principal Investigators
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Zhe Zheng, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
China National Center for Cardiovascular Diseases
Locations
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China National Center for Cardiovascular Diseases
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Zhe Zheng, M.D., Ph.D.
Role: primary
Other Identifiers
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20120618
Identifier Type: -
Identifier Source: org_study_id