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Sponsored by: |
Acusphere |
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Information provided by: | Acusphere |
ClinicalTrials.gov Identifier: | NCT00156845 |
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 coronary angiography.
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 in Patients With Suspected Ischemic Heart Disease Undergoing Diagnostic Coronary Angiography (Real-Time Assessment of Myocardial Perfusion With Echocardiography: RAMP 2) |
Estimated Enrollment: | 450 |
Study Start Date: | December 2003 |
Estimated Study Completion Date: | June 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 being evaluated for inducible ischemia and indicated for coronary angiography. 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) as the reference standard.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Eligible patients must have also undergone SPECT for evaluation of CAD within 45 calendar days prior to AI-700 administration, or be scheduled for an
Exclusion Criteria:
Study ID Numbers: | AI-700-33 |
Study First Received: | September 8, 2005 |
Last Updated: | July 13, 2006 |
ClinicalTrials.gov Identifier: | NCT00156845 History of Changes |
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 |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia |
Vascular Diseases Cardiovascular Diseases Arteriosclerosis Coronary Artery Disease |