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Hemodynamic Changes in Off-pump Coronary Artery Bypass Grafting

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00967278
First received: August 26, 2009
Last updated: August 31, 2009
Last verified: August 2009
History of Changes
  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:

U.S. FDA Resources

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

Ages Eligible for Study:   up to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: August 26, 2009
Last Updated: August 31, 2009
Health Authority: Brazil: Ministry of Health

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

ClinicalTrials.gov processed this record on June 17, 2013