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Sponsored by: |
University Health Network, Toronto |
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Information provided by: | University Health Network, Toronto |
ClinicalTrials.gov Identifier: | NCT00622024 |
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 |
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Coronary Artery Disease |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Perioperative Depression and Postoperative Arrhythmia in Elective Coronary Bypass Graft Surgery |
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
patients undergoing elective CABG surgery
Inclusion Criteria:
Exclusion Criteria:
Contact: Jo Carroll | 416-340-4800 ext 3243 | jo.carroll@uhn.on.ca |
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 |
Principal Investigator: | Rita Katznelson, MD | Toronto General Hospital, UHN |
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 |
Arrhythmia Depression Coronary Artery Disease |
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 |
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 |