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
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
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 14, 2014