Phase 3 Imaging and Safety Study of AI-700 in Patients With Suspected Coronary Artery Disease Undergoing SPECT Imaging

Completed · Phase 3

Conditions studied: Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT00156793

Run by

Acusphere

People needed

400

Starts

2003-12-01

Expected to finish

2006-03-01

Last updated by the study team

2006-07-14

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Acusphere, Inc. — Watertown, Massachusetts, United States

Full record on ClinicalTrials.gov

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