Improving Outcomes and Quality of Life After CABG

Sponsor

Weill Medical College of Cornell University (Other)

Overall Status

Completed

CT.gov ID

NCT00256620

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

412

Enrollment

Location

Duration (Months)

11.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The principal objective to this randomized trial is to compare the efficacy of two strategies of intra-operative hemodynamic management during cardiopulmonary bypass among patients undergoing primary elective coronary artery bypass graft (CABG) surgery in preventing peri-operative cardiac, cognitive and neurologic morbidity and mortality and post-operative deterioration in the patient's quality of life as measured by the seven domains of SF-36 Health Survey (bodily pain, health perceptions, energy, and mental, physical, social and role function).

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Bypass Graft Surgery Patients	Procedure: Mean arterial pressure during cardiopulmonary bypass 80 mmHg vs. customized	N/A

Detailed Description

In one group, mean arterial pressure (MAP) was 65 mmHg. In the other, the MAP target was determined by the patients usual preoperative MAP. Thus, the trial will evaluate whether tailoring the MAP target for the period of cardiopulmonary bypass to within 10 mmHg of the patients usual MAP, but < 90 mmHg (and thus achieving pressures during bypass within the patients usual autoregulatory range) reduces major neurologic and cardiac morbidity and mortality, as well as cognitive complications, thereby improving post-operative quality of life.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Single

Primary Purpose:

Prevention

Official Title:

Improving Outcomes and Quality of Life After CABG

Study Start Date :

Dec 1, 1996

Study Completion Date :

Dec 1, 1999

Outcome Measures

Primary Outcome Measures

Quality of life []
Cardiac morbidity []
Neurologic morbidity []
Mortality []
Neurocognitive deterioration []

Secondary Outcome Measures

• To evaluate the prognostic importance of severe atheromatous disease of the descending aorta as found on transesophageal echocardiography (TEE) as a predictor of neurologic events. []
• To correlate TEE and epiaortic scanning for aortic atheroma with transthoracic echocardiography (TTE) in order to develop a non-invasive screening tool. []
• To assess the clinical significance of persistent post-operative depression as measured by the CES-D by using a structured clinical interview and to evaluate the relationship between pre-operative depression and the occurrence of cardiac, neurologic a []
• To provide data on the mechanism of perioperative neurologic and cognitive complications in order to design other specific intervention to reduce postoperative morbidity. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 89 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

All patients undergoing primary elective/urgent coronary artery bypass graft (CABG) surgery.

Exclusion Criteria:

Patients who elect not to participate in the study
Patients undergoing valve replacement or other cardiovascular surgical procedures
Patients who are not fluent in English
Patient who cannot provide informed written consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York Presbyterian Hospital-Weill Medical Center	New York	New York	United States	10021

Sponsors and Collaborators

Weill Medical College of Cornell University
National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator: Mary E Charlson, MD, Weill Medical College of Cornell University
Principal Investigator: Karl Krieger, MD, Weill Medical College of Cornell University