Echocardiography: Definity 401 - Examining the Effectiveness of DEFINITY and Evaluating the Predicitive Value of Contrast Stress Echocardiography in Patient Outcomes

Study of:
DEFINITY contrast

A Phase IV Open-Label, Randomized, Multi-Center Exercise Stress trial, this echocardiographic (ultrasound) study is designed to compare the outcomes of patients who have a standard stress echocardiogram to patients who have a stress echocardiogram enhanced by DEFINITY contrast. DEFINITY is currently approved by the FDA for use when echocardiograms are difficult to read.

1,200 patients from 50 clinical sites will be enrolled in the study. Patients who qualify will be randomized (like the flip of a coin) to either receive DEFINITY contrast or placebo in 2:1 ratio. All patients will undergo baseline echocardiographic qualification examination and the exercise echocardiogram. All patients will be contacted by telephone 24?8 hours after the echocardiogram study. Ninety days after the echocardiogram, we will review the patient’s chart to see if they require additional cardiac diagnostic tests. All patients will also be contacted at 6 and 12 months.

Kevin M. Harris, MD, FACC, FASE

For more information about this study or other research studies at the Minneapolis Heart Institute and Minneapolis Heart Institute Foundation, please contact Betsy Wilson at 612-863-7065.