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Perioperative Depression and Postoperative Arrhythmia in Elective Coronary Bypass Graft Surgery
This study is currently recruiting participants.
Verified by University Health Network, Toronto, January 2008
First Received: February 11, 2008   Last Updated: February 21, 2008   History of Changes
Sponsored by: University Health Network, Toronto
Information provided by: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00622024
  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: 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:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 1
Study Start Date: January 2008
  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00622024

Contacts
Contact: Jo Carroll 416-340-4800 ext 3243 jo.carroll@uhn.on.ca

Locations
Canada, Ontario
Toronto General Hospital, UHN Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Rita Katznelson, MD         rita.katznelson@uhn.on.ca    
Principal Investigator: Rita Katznelson, MD            
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Rita Katznelson, MD Toronto General Hospital, UHN
  More Information

No publications provided

Responsible Party: Toronto General Hospital, University Health Network ( Rita Katznelson )
Study ID Numbers: REB#06-0116-AE
Study First Received: February 11, 2008
Last Updated: February 21, 2008
ClinicalTrials.gov Identifier: NCT00622024     History of Changes
Health Authority: Canada: Health Canada;   Canada: Ethics Review Committee

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

Study placed in the following topic categories:
Arterial Occlusive Diseases
Depression
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Ischemia
Arteriosclerosis
Depressive Disorder
Behavioral Symptoms
Coronary Disease
Mental Disorders
Mood Disorders
Coronary Artery Disease
Arrhythmias, Cardiac

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

ClinicalTrials.gov processed this record on September 03, 2009