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
  Purpose

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.


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Perioperative Depression and Postoperative Arrhythmia in Elective Coronary Bypass Graft Surgery

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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 ]

Enrollment: 120
Study Start Date: January 2009
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients undergoing elective CABG surgery

Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00622024

Locations
Canada, Ontario
Toronto General Hospital, UHN
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Rita Katznelson, MD Toronto General Hospital, UHN
  More Information

No publications provided by University Health Network, Toronto

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00622024     History of Changes
Other Study ID Numbers: REB#06-0116-AE
Study First Received: February 11, 2008
Last Updated: February 22, 2013
Health Authority: Canada: Health Canada
Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
Arrhythmia
Depression
Coronary Artery Disease

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Depression
Depressive Disorder
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Behavioral Symptoms
Cardiovascular Diseases
Heart Diseases
Mental Disorders
Mood Disorders
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014