- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00697723
Arterial Versus Venous Graft Recruitment by Intra-Aortic Balloon Pump
June 13, 2008 updated by: University Magna Graecia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
138
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Catanzaro, Italy, 88100
- University of Magna Graecia - Cardiac Surgery unit
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All patients undergoing coronary artery bypass surgery
Exclusion Criteria:
- Aortic insufficiency;
- Diffuse atherosclerosis impeding intra-aortic balloon pump introduction
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Hospital mortality and morbidity
Time Frame: three years
|
three years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Transit-time flowmetry
Time Frame: three years
|
three years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2005
Primary Completion (ACTUAL)
January 1, 2008
Study Completion (ACTUAL)
January 1, 2008
Study Registration Dates
First Submitted
June 11, 2008
First Submitted That Met QC Criteria
June 13, 2008
First Posted (ESTIMATE)
June 16, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
June 16, 2008
Last Update Submitted That Met QC Criteria
June 13, 2008
Last Verified
June 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UMGIABPrecruit
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.