Improving Outcomes and Quality of Life After CABG

NCT00256620 | Completed

• 1 other identifier: 9407000398 Formerly 0794-502CR
• Study Type: interventional
• Target: 412
• Locations: 1 country
• Sites: 1

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).

Conditions

Coronary Artery Bypass Graft Surgery Patients

Keywords

Cardiopulmonary bypass; Coronary artery disease; Cardiac morbidity; Neurologic morbidity; Neurocognitive function; Autoregulation

Outcome Measures

Primary Outcomes (5)

• Quality of life

• Cardiac morbidity

• Neurologic morbidity

• Mortality

• Neurocognitive deterioration

Secondary Outcomes (4)

• • 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.

Interventions

Mean arterial pressure during cardiopulmonary bypass 80 mmHg vs. customized PROCEDURE

Eligibility Criteria

• Age: 35 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

New York Presbyterian Hospital-Weill Medical Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Mary E Charlson, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

• Karl Krieger, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 17, 2005
• First Posted: November 21, 2005
• Study Start: December 1, 1996
• Study Completion: December 1, 1999
• Last Updated: April 3, 2008

Record last verified: 2008-03

Locations

US (1)