search
Back to results

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

Primary Purpose

Coronary Heart Disease

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Rosuvastatin
Placebo
Sponsored by
China National Center for Cardiovascular Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Heart Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Hospitalized patients for coronary artery bypass graft surgery

Exclusion Criteria:

  • Previous CABG surgery

Sites / Locations

  • China National Center for Cardiovascular DiseasesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

control group

statin group

Arm Description

Placebo for at least 5 days before the CABG surgery, then continue to take for a month after the surgery.

Rosuvastatin 20mg/d for at least 5 days before the CABG surgery, then continue to take for a month

Outcomes

Primary Outcome Measures

Depression
The Hamilton Depression Rating Scale (HDRS) scores
General health status
36-Item Short-From Health Survey (SF-36) scores

Secondary Outcome Measures

MACE
Composite of major adverse cardiac events (MACE) including death, myocardial infarction and/or revascularization

Full Information

First Posted
June 17, 2012
Last Updated
August 13, 2013
Sponsor
China National Center for Cardiovascular Diseases
search

1. Study Identification

Unique Protocol Identification Number
NCT01624857
Brief Title
Statin for Depression in Patients Undergoing Coronary Artery Bypass Graft
Acronym
Stress CABG
Official Title
Perioperative Statin for Depression in Patients Undergoing Coronary Artery Bypass Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
June 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China National Center for Cardiovascular Diseases

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
Placebo for at least 5 days before the CABG surgery, then continue to take for a month after the surgery.
Arm Title
statin group
Arm Type
Active Comparator
Arm Description
Rosuvastatin 20mg/d for at least 5 days before the CABG surgery, then continue to take for a month
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Intervention Description
Rosuvastatin for at least 5 days before the CABG surgery, then continue to take for a month after the surgery.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo for at least 5 days before the CABG surgery, then continue to take for a month after the surgery.
Primary Outcome Measure Information:
Title
Depression
Description
The Hamilton Depression Rating Scale (HDRS) scores
Time Frame
1 month after surgery
Title
General health status
Description
36-Item Short-From Health Survey (SF-36) scores
Time Frame
1 month after surgery
Secondary Outcome Measure Information:
Title
MACE
Description
Composite of major adverse cardiac events (MACE) including death, myocardial infarction and/or revascularization
Time Frame
6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hospitalized patients for coronary artery bypass graft surgery Exclusion Criteria: Previous CABG surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhe Zheng, M.D., Ph.D.
Phone
8610-88396051
Email
zhengzhefuwai@tom.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhe Zheng, M.D., Ph.D.
Organizational Affiliation
China National Center for Cardiovascular Diseases
Official's Role
Principal Investigator
Facility Information:
Facility Name
China National Center for Cardiovascular Diseases
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100037
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhe Zheng, M.D., Ph.D.
Phone
8610-8839-6051
Email
zhengzhefuwai@tom.com
First Name & Middle Initial & Last Name & Degree
Zhe Zheng, M.D., Ph.D.

12. IPD Sharing Statement

Learn more about this trial

Statin for Depression in Patients Undergoing Coronary Artery Bypass Graft

We'll reach out to this number within 24 hrs