Patients With History of Ischemic Heart Disease With LV Dysfunction Undergoing Noncardiac Surgery Clinical Trial
— ACTIONSOfficial title:
A Multicenter, Randomized, Controlled Pilot Study of Intra-Aortic Balloon Counterpulsation to Prevent Perioperative Cardiac Events in High-Risk Cardiac Patients Undergoing Noncardiac Surgery
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 with standard care alone, while maintaining acceptable safety with respect to vascular accesss-related complications.
Status | Terminated |
Enrollment | 1 |
Est. completion date | February 2012 |
Est. primary completion date | January 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Genesis Medical Center | Davenport | Iowa |
Lead Sponsor | Collaborator |
---|---|
Datascope Corp. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety | Amputation, Clinically significant bleeding, Vascular complications | 30 days | Yes |
Secondary | Efficacy | A composite of the following: All-cause mortality, Cardiovascular mortality, Hemorrhagic or ischemic stroke, New nonfatal myocardial infarction, New or worsening congestive heart failure, Hemodynamically significant arrhythmia requiring intervention |
30 days | No |