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Hemodynamic Changes in Off-pump Coronary Artery Bypass Grafting

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00967278
First Posted: August 27, 2009
Last Update Posted: September 1, 2009
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.
Information provided by:
University of Sao Paulo
  Purpose

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.


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Hemodynamic Changes in Off-pump Coronary Artery Bypass Grafting

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Groups/Cohorts
Off-Pump
Patients with coronary artery disease undergoing elective off-pump CABG

Detailed Description:
  • Twenty patients undergoing off-pump CABG monitored with pulmonary artery catheter and esophageal doppler will be enrolled.
  • Patients with a left ventricular ejection fraction <50%, age >80 yr, creatinine >1.4 mg/dl, reoperation, valvular heart disease or chronic obstructive pulmonary disease were excluded
  • Data will be collected after volemic and hemodynamic adjustments, after heart positioning and establishment of a suction stabilizer and before its removal in anterior, lateral or posterior wall artery anastomosis.
  • Data was compared by means of two-way repeated measures ANOVA.
  Eligibility

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Ages Eligible for Study:   up to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with coronary artery disease indicated to elective surgical treatment
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)
  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): NCT00967278


Locations
Brazil
Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, Brazil, 05403-900
Sponsors and Collaborators
University of Sao Paulo
  More Information

Responsible Party: Maria José Carvalho Carmona, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT00967278     History of Changes
Other Study ID Numbers: FAPESP 03/07092-6
First Submitted: August 26, 2009
First Posted: August 27, 2009
Last Update Posted: September 1, 2009
Last Verified: August 2009

Keywords provided by University of Sao Paulo:
OPCAB
pulmonary artery catheter
esophageal doppler
hemodynamics

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases