Perioperative Depression and Postoperative Arrhythmia in Elective Coronary Bypass Graft Surgery

Coronary Artery Disease Clinical Trial

Official title:

Perioperative Depression and Postoperative Arrhythmia in Elective Coronary Bypass Graft Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00622024
• Other study ID #: REB#06-0116-AE
• Status: Completed
• Phase: N/A
• First received: February 11, 2008
• Last updated: February 22, 2013
• Start date: January 2009
• Est. completion date: August 2011

Study information

• Verified date: February 2013
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaCanada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Canada	Toronto General Hospital, UHN	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with and without depression suffering from ventricular and/or supraventricular arrhythmias		Depression assessment and holter monitor 3days postop	No