Diastolic Dysfunction and Atrial Fibrillation in CABG Surgery

Atrial Fibrillation Clinical Trial

Official title:

Diastolic Dysfunction and Atrial Fibrillation in Patients Undergoing Coronary Revascularization Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00188903
• Other study ID #: UHN REB 03-0873-A
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: August 3, 2010
• Start date: March 2004
• Est. completion date: March 2010

Study information

• Verified date: April 2008
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: March 2010
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Fibrillation
• Heart Disease

Intervention

Procedure:
• Diastolic measurements during TEE
Transesophageal echocardiography with diastolic measurements

Locations

Country	Name	City	State
Canada	Toronto General Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Is to determine if patients with preoperative diastolic dysfunction are exposed to higher risk of AF after coronary revascularization surgery.		pre and post operative	Yes
Secondary	Is to determine if diastolic dysfunction and AF are associated with increased perioperative cardiac morbidity and reduced event-free survival.		post operative until discharge	No