Heart DiseaseNCT00188903
Diastolic Dysfunction and Atrial Fibrillation in CABG Surgery
An observational study of Heart Disease and Atrial Fibrillation, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Left ventricular (LV) diastolic dysfunction is a common manifestation of heart disease that is responsible for significant morbidity and mortality.It is present when the ventricular filling is impaired as a result of delayed relaxation or decreased compliance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Disease, Atrial Fibrillation
- What is being tested?
- Diastolic measurements during TEE
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2004to Mar 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Elective coronary artery bypass graft patients either on or off pump in acute care centre
Who may be able to join
- scheduled for elective CABG or OPCAB surgery
- signed informed consent
Who cannot join
- Patients with a history of previous heart surgery and/or undergoing valvular heart surgery.
- Patients with preoperative atrial fibrillation.
- Patients in whom TEE is contraindicated.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diastolic Dysfunction and Atrial Fibrillation in Patients Undergoing Coronary Revascularization Surgery
Left ventricular (LV) diastolic dysfunction is a common manifestation of heart disease that is responsible for significant morbidity and mortality.It is present when the ventricular filling is impaired as a result of delayed relaxation or decreased compliance. During Coronary artery bypass grafting (CABG) surgery, LV diastolic dysfunction is a frequent occurrence. Failure of the left ventricle to dilate normally causes an increase in LV filling pressure. Atrial fibrillation (AF) is a common complication after cardiac surgery affecting 20-30% of patients undergoing coronary revascularization procedures. AF is associated with significant morbidity and mortality and has been identified as a causative factor of increased length of both hospital and intensive care unit (ICU) stay after CABG surgery, resulting in increased resource utilization and medical care costs.The primary aim of this study is to determine if patients with preoperative diastolic dysfunction are exposed to higher risk of AF after coronary revascularization surgery.
- Conditions
- Heart Disease, Atrial Fibrillation
- Being tested
- Diastolic measurements during TEE
- Keywords
- Cardiac Surgery, Diastolic Dysfunction, Atrial Fibrillation
- Medical subject headings
- Heart Diseases, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diastolic measurements during TEEProcedure or surgery
Transesophageal echocardiography with diastolic measurements
What is being measured
The primary outcome is the main question the study is designed to answer.
Is to determine if patients with preoperative diastolic dysfunction are exposed to higher risk of AF after coronary revascularization surgery.
Measured: pre and post operative
Secondary outcomes (1)
Is to determine if diastolic dysfunction and AF are associated with increased perioperative cardiac morbidity and reduced event-free survival.
Measured: post operative until discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startMar 2004
- Primary completionNov 2007
- Study completionMar 2010
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 Heart 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Investigators
- George N Djaiani, MD, Principal investigator, Toronto General Hospital, Univsersity Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00188903
- Sponsor's protocol ID
- UHN REB 03-0873-A
- Status last verified
- Apr 2008
- First submitted
- 13 Sep 2005
- Last updated
- 5 Aug 2010
- Results posted
- No
Publications
Ashes CM, Yu M, Meineri M, Katznelson R, Carroll J, Rao V, Djaiani G. Diastolic dysfunction, cardiopulmonary bypass, and atrial fibrillation after coronary artery bypass graft surgery. Br J Anaesth. 2014 Nov;113(5):815-21. doi: 10.1093/bja/aeu208. Epub 2014 Jul 8.
PubMed 25005721
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diastolic Dysfunction and Atrial Fibrillation in Patients Undergoing Coronary Revascularization Surgery
- ClinicalTrials.gov ID
- NCT00188903
- Acronym / sponsor ID
- UHN REB 03-0873-A
- Conditions
- Heart Disease, Atrial Fibrillation
- Keywords
- Cardiac Surgery, Diastolic Dysfunction, Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Mar 2004
- Primary completion
- Nov 2007 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 16 Sep 2005 (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.
Left ventricular (LV) diastolic dysfunction is a common manifestation of heart disease that is responsible for significant morbidity and mortality.It is present when the ventricular filling is impaired as a result of delayed relaxation or decreased compliance. During Coronary artery bypass grafting (CABG) surgery, LV diastolic dysfunction is a frequent occurrence. Failure of the left ventricle to dilate normally causes an increase in LV filling pressure. Atrial fibrillation (AF) is a common complication after cardiac surgery affecting 20-30% of patients undergoing coronary revascularization procedures. AF is associated with significant morbidity and mortality and has been identified as a causative factor of increased length of both hospital and intensive care unit (ICU) stay after CABG surgery, resulting in increased resource utilization and medical care costs.The primary aim of this study is to determine if patients with preoperative diastolic dysfunction are exposed to higher risk of AF after coronary revascularization surgery.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Elective coronary artery bypass graft patients either on or off pump in acute care centre
Key inclusion criteria (2 listed)
- scheduled for elective CABG or OPCAB surgery
- signed informed consent
Key exclusion criteria (3 listed)
- Patients with a history of previous heart surgery and/or undergoing valvular heart surgery.
- Patients with preoperative atrial fibrillation.
- Patients in whom TEE is contraindicated.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diastolic measurements during TEETransesophageal echocardiography with diastolic measurements | Procedure or surgery | – |
Primary outcome
Is to determine if patients with preoperative diastolic dysfunction are exposed to higher risk of AF after coronary revascularization surgery.
Time frame: pre and post operative
1 secondary outcome
Is to determine if diastolic dysfunction and AF are associated with increased perioperative cardiac morbidity and reduced event-free survival.
Time frame: post operative until discharge
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 5 Aug 2010.
- Derived from this study: PubMed 25005721Ashes CM, Yu M, Meineri M, Katznelson R, Carroll J, Rao V, Djaiani G. Diastolic dysfunction, cardiopulmonary bypass, and atrial fibrillation after coronary artery bypass graft surgery. Br J Anaesth. 2014 Nov;113(5):815-21. doi: 10.1093/bja/aeu208. Epub 2014 Jul 8.
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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.
George N Djaiani, MD principal investigator
Toronto General Hospital, Univsersity Health Network
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 Heart Disease and Atrial Fibrillation, 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 3 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 5 Aug 2010. 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?
Is to determine if patients with preoperative diastolic dysfunction are exposed to higher risk of AF after coronary revascularization surgery. (time frame: pre and post operative). 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 NCT00188903, 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 5 Aug 2010.