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Sponsored by: |
Acusphere |
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Information provided by: | Acusphere |
ClinicalTrials.gov Identifier: | NCT00156793 |
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.
Condition | Intervention | Phase |
---|---|---|
Coronary Artery Disease |
Procedure: AI-700 contrast-enhanced echocardiography |
Phase III |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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) |
Estimated Enrollment: | 400 |
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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts 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 ID Numbers: | AI-700-32 |
Study First Received: | September 8, 2005 |
Last Updated: | July 13, 2006 |
ClinicalTrials.gov Identifier: | NCT00156793 |
Health Authority: | United States: Food and Drug Administration |
coronary artery disease ischemia echocardiography cardiac imaging heart disease |
myocardial contrast enhancement myocardial perfusion wall motion ultrasound contrast agent |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia |
Vascular Diseases Arteriosclerosis Ischemia Coronary Artery Disease |
Cardiovascular Diseases |