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Perioperative Depression and Postoperative Arrhythmia in Elective Coronary Bypass Graft Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00622024
First received: February 11, 2008
Last updated: February 22, 2013
Last verified: February 2013

February 11, 2008
February 22, 2013
January 2009
August 2011   (final data collection date for primary outcome measure)
Number of patients with and without depression suffering from ventricular and/or supraventricular arrhythmias [ Time Frame: Depression assessment and holter monitor 3days postop ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00622024 on ClinicalTrials.gov Archive Site
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Perioperative Depression and Postoperative Arrhythmia in Elective Coronary Bypass Graft Surgery
Perioperative Depression and Postoperative Arrhythmia in Elective Coronary Bypass Graft Surgery

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.

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Observational
Time Perspective: Prospective
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Non-Probability Sample

patients undergoing elective CABG surgery

Coronary Artery Disease
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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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
August 2011
August 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients between 18-75 years of age undergoing elective CABG surgery.
  • Patients must provide informed consent

Exclusion Criteria:

  • 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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00622024
REB#06-0116-AE
No
University Health Network, Toronto
University Health Network, Toronto
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Principal Investigator: Rita Katznelson, MD Toronto General Hospital, UHN
University Health Network, Toronto
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP