NCT00697723

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P25-P50 for phase_4 coronary-artery-disease

Timeline
Completed

Started Jan 2005

Typical duration for phase_4 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 16, 2008

Completed
Last Updated

June 16, 2008

Status Verified

June 1, 2008

Enrollment Period

3 years

First QC Date

June 11, 2008

Last Update Submit

June 13, 2008

Conditions

Coronary Artery Disease

Keywords

Coronary artery bypass graftIntra-aortic balloon pumptransit-time flowmetry

Outcome Measures

Primary Outcomes (1)

  • Hospital mortality and morbidity

    three years

Secondary Outcomes (1)

  • Transit-time flowmetry

    three years

Interventions

Transit-time flowmetryPROCEDURE

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patients undergoing coronary artery bypass surgery

You may not qualify if:

  • Aortic insufficiency;
  • Diffuse atherosclerosis impeding intra-aortic balloon pump introduction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Magna Graecia - Cardiac Surgery unit

Catanzaro, 88100, Italy

Location

Related 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. doi: 10.1016/s0003-4975(02)03663-9.

    PMID: 12400798RESULT

  • 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.

    PMID: 9237594RESULT

  • 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.

    PMID: 9725388RESULT

  • 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.

    PMID: 17893000RESULT

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 11, 2008

First Posted

June 16, 2008

Study Start

January 1, 2005

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

June 16, 2008

Record last verified: 2008-06

Locations

IT(1)