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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by China National Center for Cardiovascular Diseases.
Recruitment status was  Recruiting
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
  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

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 ] [ 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


Secondary Outcome Measures:
  • 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: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hospitalized patients for coronary artery bypass graft surgery

Exclusion Criteria:

  • Previous CABG surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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: August 13, 2013
Health Authority: China: Ministry of Health

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

ClinicalTrials.gov processed this record on October 22, 2014