ACTIONS - Aortic Counterpulsation to Improve Outcomes in Noncardiac Surgery

Stopped early · Phase 4

Conditions studied: Patients With History of Ischemic Heart Disease With LV Dysfunction Undergoing Noncardiac Surgery

In brief

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.

Key facts

Study ID

NCT01253356

Run by

Datascope Corp.

People needed

1

Starts

2011-01-01

Expected to finish

2012-02-01

Last updated by the study team

2012-01-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%)

You may not qualify if…

• 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

Where it is running

• Genesis Medical Center — Davenport, Iowa, United States

Full record on ClinicalTrials.gov

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