NCT00059319

Brief Summary

The purpose of this trial is to determine whether aortic manipulation in patients undergoing coronary bypass graft surgery leads to increased incidence of microemboli and subsequent impairment of neurobehavioral function.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Geographic Reach
1 country

1 active site

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

January 1, 1999

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 24, 2003

Completed
Last Updated

May 21, 2007

Status Verified

May 1, 2007

First QC Date

April 23, 2003

Last Update Submit

May 18, 2007

Conditions

Coronary Disease

Keywords

coronary artery bypass graft surgeryCABG surgeryneurobehavioral impairmentaorta clampingaorta manipulationmicroemboli

Interventions

single aorta clamp with retrograde cardioplegiaPROCEDURE
multiple aorta clamps with antegrade cardioplegiaPROCEDURE

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* Participants must be English-speaking patients, * 50 years of age or older, and * undergoing elective CABG surgery. * Participants of both genders and all races are eligible.

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

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • John W. Hammon, M.D.

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

April 23, 2003

First Posted

April 24, 2003

Study Start

January 1, 1999

Last Updated

May 21, 2007

Record last verified: 2007-05

Locations

US(1)