Perioperative Depression and Postoperative Arrhythmia in Elective Coronary Bypass Graft Surgery
1 other identifier
observational
120
1 country
1
Brief Summary
Postoperative arrhythmias (heart irregularities) are one of the most common complications after cardiac surgery and are associated with increased morbidity and mortality. Preoperative depression may be an important co-factor in the generation of postoperative arrhythmias due to sympathetic hyperactivity evident in patients with depression. Objectives: To determine the effect of preoperative depression on postoperative arrhythmia in patients undergoing elective coronary artery bypass graft (CABG) surgery. Prospective observational study, 120 patients undergoing elective CABG surgery ECG will be preformed preoperatively on all patients. All patients will be assessed for signs of depression using the Prime MD Patient Health Questionnaire (Prime MD PHQ) one week before surgery and 6 weeks postoperatively.Based on the Prime MD PHQ results, patients will be divided into two groups: those with or without signs of depression. Heart rate and rhythm monitoring with Holter will be performed for 3 days postoperatively in order to compare the incidence of postoperative arrhythmias between groups. The primary outcome is the number of patients with and without depression suffering from ventricular and/or supraventricular arrhythmias. Secondary outcomes include all cause mortality, non-fatal myocardial infarction, cardiac arrest, and congestive heart failure. CABG surgery is the most common operative procedure in North America and arrhythmias are one of the most common postoperative complication. It is estimated that about a third of these cardiac patients suffer from preoperative depression and therefore may be exposed to a higher risk of perioperative morbidity and mortality. If an association between preoperative depression and postoperative arrhythmia is found, treatment modalities may be indicated to reduce the prevalence of perioperative arrhythmia in patients with preoperative depression undergoing cardiac surgery.
Trial Health
Trial Health Score
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participants targeted
Target at P50-P75 for all trials
Started Jan 2009
Typical duration for all trials
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2008
CompletedFirst Posted
Study publicly available on registry
February 22, 2008
CompletedStudy Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedFebruary 25, 2013
February 1, 2013
2.6 years
February 11, 2008
February 22, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of patients with and without depression suffering from ventricular and/or supraventricular arrhythmias
Depression assessment and holter monitor 3days postop
Eligibility Criteria
patients undergoing elective CABG surgery
You may qualify if:
- Patients between 18-75 years of age undergoing elective CABG surgery.
- Patients must provide informed consent
You may not qualify if:
- Patients with a history of arrhythmias (AF, supraventricular tachycardia, ventricular tachycardia, ventricular fibrillation, permanent pacemaker and/or defibrillator).
- Patients who are unable to read.
- Patients with significant psychiatric disorders other than depression.
- Patients with a history of pulmonary hypertension.
- Patients with a left ventricular ejection fraction \< 40%.
- Patients with cognitive impairment as measured by the MMSE.
- Patients on antidepressants at the time of assessment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Toronto General Hospital, UHN
Toronto, Ontario, M5G 2C4, Canada
Related Publications (1)
Katznelson R, Scott Beattie W, Djaiani GN, Machina M, Lavi R, Rao V, Lavi S. Untreated preoperative depression is not associated with postoperative arrhythmias in CABG patients. Can J Anaesth. 2014 Jan;61(1):12-8. doi: 10.1007/s12630-013-0051-3. Epub 2013 Nov 12.
PMID: 24218191DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rita Katznelson, MD
Toronto General Hospital, UHN
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2008
First Posted
February 22, 2008
Study Start
January 1, 2009
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
February 25, 2013
Record last verified: 2013-02