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Improving Outcomes and Quality of Life After CABG

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00256620
First Posted: November 21, 2005
Last Update Posted: April 3, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
Weill Medical College of Cornell University
  Purpose
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 Intervention
Coronary Artery Bypass Graft Surgery Patients Procedure: Mean arterial pressure during cardiopulmonary bypass 80 mmHg vs. customized

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: Improving Outcomes and Quality of Life After CABG

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

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.

Estimated Enrollment: 412
Study Start Date: December 1996
Estimated Study Completion Date: December 1999
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   35 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00256620


Locations
United States, New York
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
  More Information

Responsible Party: Mary E. Charlson, MD, Weill Cornell Medical College
ClinicalTrials.gov Identifier: NCT00256620     History of Changes
Other Study ID Numbers: 9407000398 Formerly 0794-502CR
First Submitted: November 17, 2005
First Posted: November 21, 2005
Last Update Posted: April 3, 2008
Last Verified: March 2008

Keywords provided by Weill Medical College of Cornell University:
Cardiopulmonary bypass
Coronary artery disease
Cardiac morbidity
Neurologic morbidity
Neurocognitive function
Autoregulation