Coronary Artery Disease
Conditions
Keywords
Coronary Artery Bypass, Surgery
Brief summary
The purpose of this study is to determine the effect of an antidepressive medication (Escitalopram), started preoperatively and given during 6 months, on 6-month and 1 year post-operative morbidity and mortality after coronary artery bypass grafting
Detailed description
Depression is known to have an adverse effect on post-operative mortality and morbidity after coronary artery bypass grafting. Cardiac surgery is known to cause transient depression in patients. The purpose of this double-blind, randomized study is to determine the effect of an antidepressive medication (Escitalopram), started preoperatively and given during 6 months, on 6-month and 1 year post-operative morbidity and mortality after coronary artery bypass grafting. Treatment is given from 21 to 15 days pre-operatively until the 6th post-operative month. Morbidity as defined by the STS database as well as mortality is checked during 1 year.
Interventions
DRUGEscitalopram
Escitalopram 10mg or placebo once a day
Sponsors
H. Lundbeck A/S
Hopital Jean Minjoz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing elective coronary artery bypass surgery * \> 30 years old
Exclusion criteria
* Contra-indication to antidepressive treatment * Already treated by antidepressive treatment * Concomitant cardiac surgery as valve replacement etc. * Patients having anticoagulation therapy * Pregnant women * Hepatic insufficiency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative morbi-mortality | 6 months and 1 year | (1) cardiac : (2) pulmonary (3) neurologic (4) renal (5) rythm (6) infectious(7) any surgery or invasive procedure necessary to treat a postoperative adverse event associated with the initial cardiac surgery ; (8) myocardial infarction during follow-up; (9) congestive heart failure during follow-up; (10) rehospitalization for cardiac related cause, and (11) rehospitalization for non-cardiac related cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life measured by SF-36 | preoperatively and 1,3,6, and 12 months post-operatively | Influence of treatment on Quality of Life after surgery |
| Beck depression index (BDI) and Center for Epidemiologic Studies Depression (CES-D) Scale | preoperatively, and 1,3,6, and 12 months post-operatively. | Morbi-mortaity and quality of life according to preoperative values of BDI and/or CES-D |
Countries
France
Outcome results
None listed