Back to resultsArterial Versus Venous Graft Recruitment by Intra-Aortic Balloon Pump
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Transit-time flowmetry
Sponsored by
About this trial
This is an interventional supportive care trial for Coronary Artery Disease focused on measuring Coronary artery bypass graft, Intra-aortic balloon pump, transit-time flowmetry
Eligibility Criteria
Inclusion Criteria:
- All patients undergoing coronary artery bypass surgery
Exclusion Criteria:
- Aortic insufficiency;
- Diffuse atherosclerosis impeding intra-aortic balloon pump introduction
Sites / Locations
- University of Magna Graecia - Cardiac Surgery unit
Outcomes
Primary Outcome Measures
Hospital mortality and morbidity
Secondary Outcome Measures
Transit-time flowmetry
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00697723
Brief Title
Arterial Versus Venous Graft Recruitment by Intra-Aortic Balloon Pump
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Magna Graecia
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary artery bypass graft, Intra-aortic balloon pump, transit-time flowmetry
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
138 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Transit-time flowmetry
Intervention Description
Transit-time flowmetry during 1:1 IABP assistance and when IABP is turned off
Primary Outcome Measure Information:
Title
Hospital mortality and morbidity
Time Frame
three years
Secondary Outcome Measure Information:
Title
Transit-time flowmetry
Time Frame
three years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients undergoing coronary artery bypass surgery
Exclusion Criteria:
Aortic insufficiency;
Diffuse atherosclerosis impeding intra-aortic balloon pump introduction
Facility Information:
Facility Name
University of Magna Graecia - Cardiac Surgery unit
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
12400798
Citation
Baskett RJ, Ghali WA, Maitland A, Hirsch GM. The intraaortic balloon pump in cardiac surgery. Ann Thorac Surg. 2002 Oct;74(4):1276-87. doi: 10.1016/s0003-4975(02)03663-9.
Results Reference
result
PubMed Identifier
9237594
Citation
Christenson JT, Simonet F, Badel P, Schmuziger M. Evaluation of preoperative intra-aortic balloon pump support in high risk coronary patients. Eur J Cardiothorac Surg. 1997 Jun;11(6):1097-103; discussion 1104. doi: 10.1016/s1010-7940(97)00087-0.
Results Reference
result
PubMed Identifier
9725388
Citation
Tedoriya T, Kawasuji M, Sakakibara N, Takemura H, Watanabe Y, Hetzer R. Coronary bypass flow during use of intraaortic balloon pumping and left ventricular assist device. Ann Thorac Surg. 1998 Aug;66(2):477-81. doi: 10.1016/s0003-4975(98)00468-8.
Results Reference
result
PubMed Identifier
17893000
Citation
Yoshitani H, Akasaka T, Kaji S, Kawamoto T, Kume T, Neishi Y, Koyama Y, Yoshida K. Effects of intra-aortic balloon counterpulsation on coronary pressure in patients with stenotic coronary arteries. Am Heart J. 2007 Oct;154(4):725-31. doi: 10.1016/j.ahj.2007.05.019.
Results Reference
result
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Arterial Versus Venous Graft Recruitment by Intra-Aortic Balloon Pump
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