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

History of Changes

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:

MedlinePlus related topics: Coronary Artery Bypass Surgery Coronary Artery Disease

U.S. FDA Resources

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:

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:

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.

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.

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.

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.

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 May 19, 2013

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