ACTIONS - Aortic Counterpulsation to Improve Outcomes in Noncardiac Surgery (ACTIONS)
Primary Purpose
Patients With History of Ischemic Heart Disease With LV Dysfunction Undergoing Noncardiac Surgery
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
IABP
Sponsored by
About this trial
This is an interventional prevention trial for Patients With History of Ischemic Heart Disease With LV Dysfunction Undergoing Noncardiac Surgery
Eligibility Criteria
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
Sites / Locations
- Genesis Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
No IABP
Intra-Aortic Balloon Pump (IABP)
Arm Description
Standard of care and no IABP
Standard of care, IABP inserted < or = 3 hours before noncardiac surgery, maintained for > or = 12-24 hours after surgery
Outcomes
Primary Outcome Measures
Safety
Amputation, Clinically significant bleeding, Vascular complications
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01253356
Brief Title
ACTIONS - Aortic Counterpulsation to Improve Outcomes in Noncardiac Surgery
Acronym
ACTIONS
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Terminated
Why Stopped
Only 1 patient recruited and deemed ineligible.
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2012 (Anticipated)
Study Completion Date
February 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Datascope Corp.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 with standard care alone, while maintaining acceptable safety with respect to vascular accesss-related complications.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With History of Ischemic Heart Disease With LV Dysfunction Undergoing Noncardiac Surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No IABP
Arm Type
No Intervention
Arm Description
Standard of care and no IABP
Arm Title
Intra-Aortic Balloon Pump (IABP)
Arm Type
Active Comparator
Arm Description
Standard of care, IABP inserted < or = 3 hours before noncardiac surgery, maintained for > or = 12-24 hours after surgery
Intervention Type
Device
Intervention Name(s)
IABP
Intervention Description
Insertion of intra-aortic balloon < or = 3 hours before noncardiac surgery and maintained > or = 12-24 hours after surgery
Primary Outcome Measure Information:
Title
Safety
Description
Amputation, Clinically significant bleeding, Vascular complications
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Efficacy
Description
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
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Don Poldermans, MD
Organizational Affiliation
Erasmus Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Genesis Medical Center
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52803
Country
United States
12. IPD Sharing Statement
Learn more about this trial
ACTIONS - Aortic Counterpulsation to Improve Outcomes in Noncardiac Surgery
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