NCT00967278

Brief Summary

The purpose of this study is to study the positioning and stabilization of different cardiac walls performed during off-pump coronary artery bypass grafting (CABG) may have dissimilar impact on hemodynamics. The objective is to evaluate hemodynamics during distal coronary anastomoses in different cardiac walls.

Trial Health

80
On Track

Trial Health Score

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

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

First Submitted

Initial submission to the registry

August 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 27, 2009

Completed
Last Updated

September 1, 2009

Status Verified

August 1, 2009

First QC Date

August 26, 2009

Last Update Submit

August 31, 2009

Conditions

Coronary Artery Disease

Keywords

OPCABpulmonary artery catheteresophageal dopplerhemodynamics

Study Arms (1)

Off-Pump

Patients with coronary artery disease undergoing elective off-pump CABG

Eligibility Criteria

AgeUp to 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with coronary artery disease indicated to elective surgical treatment

You may qualify if:

  • Normal left ventricular function
  • Minimal to moderate surgical risk according to criteria proposed by Higgins et al. (JAMA. 1992 May 6;267(17):2344-8)

You may not qualify if:

  • Patients with a left ventricular ejection fraction \<50%,
  • Age \>80 yr
  • Creatinine \>1.4 mg/dl
  • Reoperation
  • Valvular heart disease
  • Chronic obstructive pulmonary disease
  • High surgical risk according to criteria proposed by Higgins et al. (JAMA. 1992 May 6;267(17):2344-8)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, São Paulo, 05403-900, Brazil

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 26, 2009

First Posted

August 27, 2009

Last Updated

September 1, 2009

Record last verified: 2009-08

Locations

BR(1)