NCT00622024

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 22, 2008

Completed
10 months until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

February 25, 2013

Status Verified

February 1, 2013

Enrollment Period

2.6 years

First QC Date

February 11, 2008

Last Update Submit

February 22, 2013

Conditions

Keywords

ArrhythmiaDepressionCoronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Number of patients with and without depression suffering from ventricular and/or supraventricular arrhythmias

    Depression assessment and holter monitor 3days postop

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients undergoing elective CABG surgery

You may qualify if:

  • Patients between 18-75 years of age undergoing elective CABG surgery.
  • Patients must provide informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto General Hospital, UHN

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Coronary Artery DiseaseArrhythmias, CardiacDepression

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Study Officials

  • Rita Katznelson, MD

    Toronto General Hospital, UHN

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2008

First Posted

February 22, 2008

Study Start

January 1, 2009

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

February 25, 2013

Record last verified: 2013-02

Locations