Coronary Artery DiseaseNCT00622024
Perioperative Depression and Postoperative Arrhythmia in Elective Coronary Bypass Graft Surgery
An observational study of Coronary Artery Disease, run by University Health Network, Toronto at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2009to Aug 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing elective CABG surgery
Who may be able to join
- Patients between 18-75 years of age undergoing elective CABG surgery.
- Patients must provide informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Coronary Artery Disease
- Keywords
- Arrhythmia, Depression, Coronary Artery Disease
- Medical subject headings
- Coronary Artery Disease, Arrhythmias, Cardiac, Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with and without depression suffering from ventricular and/or supraventricular arrhythmias
Measured: Depression assessment and holter monitor 3days postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2008 (estimated)
- Study startJan 2009
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rita Katznelson, MD, Principal investigator, Toronto General Hospital, UHN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00622024
- Sponsor's protocol ID
- REB#06-0116-AE
- Status last verified
- Feb 2013
- First submitted
- 11 Feb 2008
- Last updated
- 25 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24218191
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Depression and Postoperative Arrhythmia in Elective Coronary Bypass Graft Surgery
- ClinicalTrials.gov ID
- NCT00622024
- Acronym / sponsor ID
- REB#06-0116-AE
- Conditions
- Coronary Artery Disease
- Keywords
- Arrhythmia, Depression, Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 22 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing elective CABG surgery
Key inclusion criteria (2 listed)
- Patients between 18-75 years of age undergoing elective CABG surgery.
- Patients must provide informed consent
Key exclusion criteria (7 listed)
- 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%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients with and without depression suffering from ventricular and/or supraventricular arrhythmias
Time frame: Depression assessment and holter monitor 3days postop
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2013.
- Derived from this study: PubMed 24218191Katznelson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rita Katznelson, MD principal investigator
Toronto General Hospital, UHN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with and without depression suffering from ventricular and/or supraventricular arrhythmias (time frame: Depression assessment and holter monitor 3days postop). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00622024, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2013.