Phase 3 Safety and Imaging Study of AI-700 in Patients with Suspected Coronary Artery Disease Undergoing Coronary Angiography - Article CABG
Clinical Trial: Phase 3 Safety and Imaging Study of AI-700 in Patients with Suspected Coronary Artery Disease Undergoing Coronary Angiography
This study is currently recruiting patients.
Verified by Acusphere September 2005
|Coronary Artery Disease || Procedure: AI-700 contrast-enhanced echocardiography ||Phase III |
MedlinePlus related topics: Coronary Disease
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
Expected Total Enrollment: 400
Study start: December 2003
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 is to determine the sensitivity and specificity of AI-700-enhanced echocardiographic imaging for detecting CAD, using coronary angiography/left ventriculography (ANGIO/LVG) as the reference standard.
- Men and non-pregnant/non-lactating women who are 18 to 80 years of age and who have recently undergone coronary angiography or are scheduled for coronary angiography within 30 days after AI-700 administration will be enrolled. Eligible patients must also have undergone SPECT for evaluation of CAD within 45 calendar days prior to AI-700 administration, or be scheduled for an “on-study” SPECT on the same day as AI-700 dosing or an “off-study” SPECT within 15 days following AI-700 dosing.
- Study candidates who have or have had any of the following conditions will 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; previous coronary artery bypass graft; moderate to severe chronic obstructive pulmonary disease; or oxygen saturation < 90% at rest.
- 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, are not eligible to participate in the study.
- Patients who have history of MI of non-CAD etiology or who exhibit new or changing ECG abnormalities at any time between Screening and AI-700 dosing will be similarly excluded.
- Other exclusion criteria include: participation in an investigational drug/device study within 30 days prior to dosing, 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 will 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 has not been evaluated and treated by a specialist or for which current treatment does not ensure patient safety.
- Candidates who have used methylated xanthines within 24 hours of dosing will also be excluded. Patients will also be excluded if aminophylline, theophylline, or dipyridamole are contraindicated according to each agent’s product labeling.
Location and Contact Information
Acusphere, Inc., Watertown, Massachusetts, 02472, United States; Recruiting
Last Updated: September 10, 2005
Record first received: September 8, 2005
ClinicalTrials.gov Identifier: NCT00156845
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13