Coronary Artery Disease
Conditions
Keywords
coronary artery disease, ischemia, echocardiography, cardiac imaging, heart disease, myocardial contrast enhancement, myocardial perfusion, wall motion, ultrasound contrast agent
Brief summary
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.
Detailed description
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.
Interventions
Sponsors
Acusphere
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
-Men and non-pregnant/non-lactating women with a recent history of typical or atypical chest pain (angina) who were 18 to 80 years of age and who had been clinically indicated for SPECT evaluation for the presence of inducible ischemia were to be enrolled.
Exclusion criteria
* Study candidates who have had any of the following conditions were to be excluded from the study: any clinically unstable condition or major surgery within 7 days prior to AI-700 dosing; an acute MI, cerebrovascular accident or transient ischemic attack within 30 days prior to dosing; congestive heart failure graded as New York Heart Association Grade 4 within 3 months prior to dosing; significant left main CAD; moderate to severe chronic obstructive pulmonary disease; oxygen saturation \< 90% at rest; or prior CABG (unless \>= 6 months prior to AI-700 dosing and patient had typical angina) * Candidates with significant cardiovascular or pulmonary structural and/or functional abnormality, or in whom visualization of the left ventricle was not adequate for evaluation of cardiac function during the Exclusion ECHO, were not eligible to participate in the study. * Patients who had a history of MI of non-CAD etiology or who exhibited new or changing ECG abnormalities at any time between Screening and AI-700 dosing were to be similarly excluded. * Other
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accuracy, sensitivity, and specificity of AI-700 ECHO in assessing CAD | — |
| Safety of AI-700 administered IV to suspected CAD patients | — |
Countries
United States
Outcome results
None listed