NCT00005690

Brief Summary

Among patients undergoing elective primary coronary artery bypass graft (CABG), the principal objective of this randomized trial was to compare the efficacy of two strategies of intra-operative hemodynamic management during cardiopulmonary bypass in preventing peri-operative cardiac, cognitive and neurologic morbidity and mortality, and post-operative deterioration in patients' quality of life as measured by the SF-36.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Aug 1991

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1991

Completed
8.8 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 26, 2000

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2000

Completed
Last Updated

May 13, 2016

Status Verified

January 1, 2005

First QC Date

May 25, 2000

Last Update Submit

May 12, 2016

Conditions

Cardiovascular DiseasesHeart DiseasesCoronary Disease

Eligibility Criteria

AgeUp to 100 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
No eligibility criteria

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (8)

  • Gold JP, Charlson ME, Williams-Russo P, Szatrowski TP, Peterson JC, Pirraglia PA, Hartman GS, Yao FS, Hollenberg JP, Barbut D, et al. Improvement of outcomes after coronary artery bypass. A randomized trial comparing intraoperative high versus low mean arterial pressure. J Thorac Cardiovasc Surg. 1995 Nov;110(5):1302-11; discussion 1311-4. doi: 10.1016/S0022-5223(95)70053-6.

    PMID: 7475182BACKGROUND

  • Hartman GS, Peterson J, Konstadt SN, Hahn R, Szatrowski TP, Charlson ME, Bruefach M 3rd. High reproducibility in the interpretation of intraoperative transesophageal echocardiographic evaluation of aortic atheromatous disease. Anesth Analg. 1996 Mar;82(3):539-43. doi: 10.1097/00000539-199603000-00020.

    PMID: 8623958BACKGROUND

  • Hollenberg JP, Pirraglia PA, Williams-Russo P, Hartman GS, Gold JP, Yao FS, Thomas SJ. Computerized data collection in the operating room during coronary artery bypass surgery: a comparison to the hand-written anesthesia record. J Cardiothorac Vasc Anesth. 1997 Aug;11(5):545-51. doi: 10.1016/s1053-0770(97)90001-x.

    PMID: 9263082BACKGROUND

  • Hartman GS, Yao FS, Bruefach M 3rd, Barbut D, Peterson JC, Purcell MH, Charlson ME, Gold JP, Thomas SJ, Szatrowski TP. Severity of aortic atheromatous disease diagnosed by transesophageal echocardiography predicts stroke and other outcomes associated with coronary artery surgery: a prospective study. Anesth Analg. 1996 Oct;83(4):701-8. doi: 10.1097/00000539-199610000-00007.

    PMID: 8831306BACKGROUND

  • Charlson M, Krieger KH, Peterson JC, Hayes J, Isom OW. Predictors and outcomes of cardiac complications following elective coronary bypass grafting. Proc Assoc Am Physicians. 1999 Nov-Dec;111(6):622-32. doi: 10.1046/j.1525-1381.1999.99130.x.

    PMID: 10591092BACKGROUND

  • Pirraglia PA, Peterson JC, Williams-Russo P, Gorkin L, Charlson ME. Depressive symptomatology in coronary artery bypass graft surgery patients. Int J Geriatr Psychiatry. 1999 Aug;14(8):668-80. doi: 10.1002/(sici)1099-1166(199908)14:83.0.co;2-9.

    PMID: 10489658BACKGROUND

  • Pirraglia PA, Peterson JC, Hartman GS, Yao FS, Thomas SJ, Charlson ME. The efficacy and safety of a pharmacologic protocol for maintaining coronary artery bypass patients at a higher mean arterial pressure during cardiopulmonary bypass. J Extra Corpor Technol. 1998 Jun;30(2):64-72.

    PMID: 10182115BACKGROUND

  • Peterson JC, Charlson ME, Williams-Russo P, Krieger KH, Pirraglia PA, Meyers BS, Alexopoulos GS. New postoperative depressive symptoms and long-term cardiac outcomes after coronary artery bypass surgery. Am J Geriatr Psychiatry. 2002 Mar-Apr;10(2):192-8.

    PMID: 11925280BACKGROUND

MeSH Terms

Conditions

Cardiovascular DiseasesHeart DiseasesCoronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaVascular Diseases

Study Officials

  • Mary Charlson

    Weill Medical College of Cornell University

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

May 25, 2000

First Posted

May 26, 2000

Study Start

August 1, 1991

Study Completion

November 1, 2000

Last Updated

May 13, 2016

Record last verified: 2005-01