Novel Agent for Echo May Be as Effective as Nuclear Perfusion
November 6, 2007 - Acusphere Inc. announced that Imagify Perfusion Stress Echo, an investigational new drug developed to assess perfusion using ultrasound (or echocardiography) for the detection of coronary heart disease, was shown to be just as good at determining whether or not a patient has disease (accuracy), according to data from two studies released today at the AHA meeting.
The results were derived from Phase 3 RAMP-1 (real time assessment of myocardial perfusion) and RAMP-2 clinical trials of Imagify (Perflubutane Polymer Microspheres for injectable suspension. Imagify is the first echocardiography imaging agent designed and shown in clinical trials to assess blood flow in the heart (perfusion). Myocardial perfusion is a sensitive marker of coronary heart disease (CHD).
Currently, perfusion information is not available using echocardiography (cardiac ultrasound), but must be obtained using a nuclear stress test. Imagify Perfusion Stress Echo would have many potential benefits over nuclear stress testing, said the manufacturer, including quicker results, lower cost and no exposure to radioactivity.
“The benefits of this important new approach for patients and physicians are very clear: ultrasound equipment is widely available, faster to use and far less expensive compared to nuclear stress testing. In addition, since there is no radiation involved, it is safer for the patient and eliminates hazardous waste disposal for the facility,” said Roxy Senior, M.D., Director of Echocardiology in the Department of Cardiology at Northwick Park Hospital and the Imperial College of Medicine, London UK, and the lead investigator in the RAMP -1 and -2 Phase 3 trials.
According to the Phase 3 data presented today at the American Heart Association’s Scientific Sessions, when compared to nuclear stress — the most frequently used imaging procedure for the assessment of coronary heart disease – Imagify Perfusion Stress Echo was shown to be:
* Just as good at determining whether or not a patient has disease (accuracy)
* Superior in ruling out disease in patients with a lower prevalence of disease (specificity)
* Superior in detecting disease in patients with a higher prevalence of disease (sensitivity)
“While the currently available echo technology can detect wall motion abnormalities one of the hallmarks of coronary artery disease, the detection of a patient’s myocardial blood flow would add a critical piece of the diagnostic puzzle when evaluating patients with heart ultrasound for their risk for heart attack. The results of the RAMP trials reported today suggest that Imagify will enable assessment of wall motion and blood flow, which when combined, is a stronger predictor of coronary artery disease than either finding alone,” said Michael Picard, M.D., Director, Clinical Echocardiography at Massachusetts General Hospital Heart Center and clinical monitor for the RAMP-2 trial.
• Accuracy: 3 of 3 ultrasound blinded readers were non-inferior (p<0.004)
• Sensitivity: 1 of 3 ultrasound blinded readers was non-inferior (p=0.002)
• Specificity: 2 of 3 ultrasound blinded readers were superior (p<0.006)
• Accuracy: 3 of 3 ultrasound blinded readers were non-inferior (p< 0.001)
• Sensitivity: 3 of 3 ultrasound blinded readers were superior (p<0.002)
• Specificity: 1 of 3 ultrasound blinded readers was non-inferior (p=0.013)
For more information: www.acusphere.com