Clinical trial NCT00622024: Perioperative Depression and Postoperative Arrhythmia in Elective Coronary Bypass Graft Surgery
Official title: Perioperative Depression and Postoperative Arrhythmia in Elective Coronary Bypass Graft Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Arrhythmia
Depression
Coronary Artery Disease
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2008-02-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing elective CABG surgery

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.


Eligibility 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

Primary outcomes:
measure: Number of patients with and without depression suffering from ventricular and/or supraventricular arrhythmias
timeFrame: Depression assessment and holter monitor 3days postop
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital, UHN
state: Ontario
Study officials:
affiliation: Toronto General Hospital, UHN
name: Rita Katznelson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.