Arterial Versus Venous Graft Recruitment by Intra-Aortic Balloon Pump

This study has been completed.
Sponsor:
Information provided by:
University Magna Graecia
ClinicalTrials.gov Identifier:
NCT00697723
First received: June 11, 2008
Last updated: June 13, 2008
Last verified: June 2008
  Purpose

The aim of this study is to evaluate the different performance of arterial and venous graft with intra-aortic balloon pump support following coronary artery bypass.


Condition Intervention Phase
Coronary Artery Disease
Procedure: Transit-time flowmetry
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care

Resource links provided by NLM:


Further study details as provided by University Magna Graecia:

Primary Outcome Measures:
  • Hospital mortality and morbidity [ Time Frame: three years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Transit-time flowmetry [ Time Frame: three years ] [ Designated as safety issue: Yes ]

Enrollment: 138
Study Start Date: January 2005
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Transit-time flowmetry
    Transit-time flowmetry during 1:1 IABP assistance and when IABP is turned off
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients undergoing coronary artery bypass surgery

Exclusion Criteria:

  • Aortic insufficiency;
  • Diffuse atherosclerosis impeding intra-aortic balloon pump introduction
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00697723

Locations
Italy
University of Magna Graecia - Cardiac Surgery unit
Catanzaro, Italy, 88100
Sponsors and Collaborators
University Magna Graecia
  More Information

Publications:
Responsible Party: University of Magna Graecia - Cardiac Surgery Unit
ClinicalTrials.gov Identifier: NCT00697723     History of Changes
Other Study ID Numbers: UMGIABPrecruit
Study First Received: June 11, 2008
Last Updated: June 13, 2008
Health Authority: Italy: Ethics Committee

Keywords provided by University Magna Graecia:
Coronary artery bypass graft
Intra-aortic balloon pump
transit-time flowmetry

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

ClinicalTrials.gov processed this record on October 30, 2014