Phase 3 Imaging and Safety Study of AI-700 in Patients With Suspected Coronary Artery Disease Undergoing SPECT Imaging
This study was designed to evaluate the ability of AI-700-enhanced rest-stress echocardiography to detect coronary artery disease (CAD) in patients with suspected ischemic heart disease who are indicated for single-photon emission computed tomography (SPECT) imaging.
Coronary Artery Disease
Procedure: AI-700 contrast-enhanced echocardiography
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||A Phase 3, International, Multicenter, Open Label, Dual-Injection, Echocardiographic Imaging and Safety Study of AI-700 in Patients With Suspected Ischemic Heart Disease Undergoing Single-Photon Emission Computed Tomography (Real-Time Assessment of Myocardial Perfusion With Echocardiography: RAMP 1)|
- Accuracy, sensitivity, and specificity of AI-700 ECHO in assessing CAD
- Safety of AI-700 administered IV to suspected CAD patients
|Study Start Date:||December 2003|
|Estimated Study Completion Date:||March 2006|
Assessment of myocardial perfusion has been demonstrated to provide both diagnostic and prognostic value to patients with ischemic heart disease by allowing the clinician to assess the hemodynamic significance of coronary artery disease (CAD). The primary objective of the clinical development program for AI-700 is to demonstrate the safety and efficacy of AI-700 as an intravenous ultrasound contrast agent in patients with suspected myocardial perfusion defects.
The patient population is comprised of patients who are being evaluated for inducible ischemia. The primary study objective was to determine the accuracy, sensitivity, and specificity of AI-700-enhanced echocardiographic imaging for detecting CAD using coronary angiography/left ventriculography (ANGIO/LVG) or single-photon emission computed tomography (SPECT) with clinical outcome as the reference standards.