Acusphere Inc. announced that in a test on Imagify, its ultrasound contrast agent, all three of the ultrasound-blinded readers had superior sensitivity and noninferior accuracy to nuclear stress, the most frequently used imaging procedure for the assessment of coronary artery disease.
Imagify is the first ultrasound contrast agent designed to assess perfusion. In the RAMP-2 test, its second Phase 3 clinical trial of Imagify, the company set out to demonstrate that Imagify-enhanced cardiac stress ultrasound is noninferior to nuclear stress. Results were as follows:
Accuracy: Three of three ultrasound-blinded readers were noninferior (p less than or equal to 0.001).
Sensitivity: Three of three ultrasound-blinded readers were superior (p less than or equal to 0.020).
Specificity: One of three ultrasound blinded readers was noninferior (p = 0.01).
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