- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00156793
Phase 3 Imaging and Safety Study of AI-700 in Patients With Suspected Coronary Artery Disease Undergoing SPECT Imaging
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)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Locations
-
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Massachusetts
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Watertown, Massachusetts, United States, 02472
- Acusphere, Inc.
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 exclusion criteria included: participation in an investigational drug/device study within 30 days prior to dosing (90 days for UK sites), non-seasonal asthma within the past 3 years or recent seasonal asthma requiring prescription medication, organ transplant or end-stage organ failure, and active seizure disorder.
- Candidates were to be excluded for uncontrolled atrial fibrillation, frequent premature ventricular or atrial contractions, history of prolonged QT/QTc, use of automatic implantable cardioverter/defibrillator or pacemaker, and any rhythm abnormality that had not been evaluated and treated by a specialist or for which current treatment did not ensure patient safety.
- Candidates who had used methylated xanthines within 24 hours of dosing were also to be excluded. Patients were also to be excluded if aminophylline, theophylline, or dipyridamole were contraindicated according to each agent's product labeling.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Accuracy, sensitivity, and specificity of AI-700 ECHO in assessing CAD
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Safety of AI-700 administered IV to suspected CAD patients
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AI-700-32
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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