Diastolic Dysfunction and Atrial Fibrillation in CABG Surgery

August 3, 2010 updated by: University Health Network, Toronto

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Procedure: Diastolic measurements during TEE

Study Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- Ontario
  - Toronto, Ontario, Canada, M5G 2C4
    - Toronto General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Elective coronary artery bypass graft patients either on or off pump in acute care centre

Description

Inclusion Criteria:

scheduled for elective CABG or OPCAB surgery
signed informed consent

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	pre and post operative

Secondary Outcome Measures

Outcome Measure	Time Frame
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	post operative until discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

Principal Investigator: George N Djaiani, MD, Toronto General Hospital, Univsersity Health Network

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria