Status:
TERMINATED
ACTIONS - Aortic Counterpulsation to Improve Outcomes in Noncardiac Surgery
Lead Sponsor:
Datascope Corp.
Conditions:
Patients With History of Ischemic Heart Disease With LV Dysfunction Undergoing Noncardiac Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The use of the IABP, in addition to standard care, in high-risk cardiac patients undergoing major noncardiac surgery is feasible and may result in improved perioperative outcomes at 30 days compared w...
Eligibility Criteria
Inclusion
- Patients \> 18 years with planned elective major abdominal, noncardiac thoracic, head and neck, vascular, or orthopedic surgery and guideline-treated iscehmic heart disease with left ventricular dysfunction (systolic ejection fraction \< or = 30%)
Exclusion
- Unstable coronary syndromes Decompensated or NYHA Class IV heart failure Hemodynamic instability Cardiac biomarker instability Need for surgical procedure interfering with placement of IABP Cardiogenic shock Septic shock Contraindication to IABP use Clinical need for IABP ASA score \> or = 5 Pregnancy Inability to provide informed consent
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01253356
Start Date
January 1 2011
End Date
February 1 2012
Last Update
January 6 2012
Active Locations (1)
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1
Genesis Medical Center
Davenport, Iowa, United States, 52803