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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2012 by China National Center for Cardiovascular Diseases.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01624857
First Posted: June 21, 2012
Last Update Posted: August 15, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
China National Center for Cardiovascular Diseases
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Perioperative Statin for Depression in Patients Undergoing Coronary Artery Bypass Surgery

Resource links provided by NLM:


Further study details as provided by China National Center for Cardiovascular Diseases:

Primary Outcome Measures:
  • Depression [ Time Frame: 1 month after surgery ]
    The Hamilton Depression Rating Scale (HDRS) scores

  • General health status [ Time Frame: 1 month after surgery ]
    36-Item Short-From Health Survey (SF-36) scores


Secondary Outcome Measures:
  • MACE [ Time Frame: 6 month ]
    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: June 2014
Estimated Primary Completion Date: December 2013 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hospitalized patients for coronary artery bypass graft surgery

Exclusion Criteria:

  • Previous CABG surgery
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01624857


Contacts
Contact: Zhe Zheng, M.D., Ph.D. 8610-88396051 zhengzhefuwai@tom.com

Locations
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.         
Sponsors and Collaborators
China National Center for Cardiovascular Diseases
Investigators
Principal Investigator: Zhe Zheng, M.D., Ph.D. China National Center for Cardiovascular Diseases
  More Information

Responsible Party: China National Center for Cardiovascular Diseases
ClinicalTrials.gov Identifier: NCT01624857     History of Changes
Other Study ID Numbers: 20120618
First Submitted: June 17, 2012
First Posted: June 21, 2012
Last Update Posted: August 15, 2013
Last Verified: May 2012

Additional relevant MeSH terms:
Depression
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Behavioral Symptoms
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Rosuvastatin Calcium
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents


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