Arterial Versus Venous Graft Recruitment by Intra-Aortic Balloon Pump

Coronary Artery Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00697723
• Other study ID #: UMGIABPrecruit
• Status: Completed
• Phase: Phase 4
• First received: June 11, 2008
• Last updated: June 13, 2008
• Start date: January 2005
• Est. completion date: January 2008

Study information

• Verified date: June 2008
• Source: University Magna Graecia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients undergoing coronary artery bypass surgery

Exclusion Criteria:

• Aortic insufficiency;

• Diffuse atherosclerosis impeding intra-aortic balloon pump introduction

Study Design

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• Transit-time flowmetry
Transit-time flowmetry during 1:1 IABP assistance and when IABP is turned off

Locations

Country	Name	City	State
Italy	University of Magna Graecia - Cardiac Surgery unit	Catanzaro

Sponsors (1)

Lead Sponsor	Collaborator
University Magna Graecia

Country where clinical trial is conducted

Italy, 

References & Publications (4)

Baskett RJ, Ghali WA, Maitland A, Hirsch GM. The intraaortic balloon pump in cardiac surgery. Ann Thorac Surg. 2002 Oct;74(4):1276-87. Review. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital mortality and morbidity		three years	Yes
Secondary	Transit-time flowmetry		three years	Yes