A Phase 3, International, Exploratory, Open-Label, Multicenter, Dual-Injection, Echocardiographic Imaging Settings and Safety Study of AI-700 in Normal Volunteers and Stable Cardiac Patients (Acquiring Consensus for Contrast Echocardiography System Settings - ACCESS Study) - ACCESS
- Conditions
- AI-700 is an intravenous (IV) ultrasound contrast agent designed for echocardiographic imaging for myocardial defect detection.MedDRA version: 8.1 Level: LLT Classification code 10061024 Term: Cardiac disorder
- Registration Number
- EUCTR2006-003012-21-GB
- Lead Sponsor
- Acusphere, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
Up to 60 men and non-pregnant/non-lactating women who are 18 to 70 years of age and who have undergone echocardiographic imaging within 14 days before AI-700 administration will be enrolled. The study will include both healthy volunteers and stable cardiac patient candidates.
Inclusion Criteria – Healthy Volunteers
• Male or female between 18 and 70 years of age;
• In good health, as determined by medical history, physical examination, vital signs, and 12-lead ECG;
• If female, must be at least 1 year post-menopausal or surgically sterile; or be sexually abstinent or have a sterile sexual partner; or from 4 weeks before dosing until 30 days post-dosing use oral, implantable, or injectable contraceptives or an approved form of contraception (including intrauterine device [IUD], female condom, diaphragm with spermicidal, cervical cap, or use of a condom by sexual partner);
• If female, have a negative serum pregnancy test within 24 hours of AI-700 if pre-menopausal or <1 year post menopausal;
• Willingness to provide the Sponsor with access to data associated with his/her Qualification Echo performed during the 14 days prior to AI-700 dosing;
• Able to comprehend and willing to sign an informed consent form;
• Must have a low chance of coronary artery disease (CAD) as defined by medical history, ECG, the Qualification Echo, CAD risk factors, and (if available) a negative nuclear imaging study and/or a negative ECG stress test.
Inclusion Criteria – Stable Cardiac Patients
• Male or female and 18 to 70 years of age;
• In stable health, as determined by medical history, physical examination, vital signs, and 12 lead ECG;
• History of myocardial infarction (MI) and/or coronary artery revascularization procedure at least 90 days prior to AI-700 dosing;
• Willingness to provide the Sponsor with access to data associated with his/her Qualification Echo performed during the 14 days prior to AI-700 dosing;
• If female, must be at least 1 year post-menopausal or surgically sterile; or be sexually abstinent or have a sterile sexual partner; or from 4 weeks before dosing until 30 days post-dosing use oral, implantable, or injectable contraceptives or an approved form of contraception (including intrauterine device (IUD), female condom, diaphragm with spermicidal, cervical cap, or use of a condom by sexual partner);
• If female, have a negative serum pregnancy test within 24 hours of AI-700 if pre-menopausal or <1 year post-menopausal;
• Able to comprehend and willing to sign an informed consent form.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria - Healthy Volunteers
• Significant intra-cardiac shunt or any other cardiovascular structural and/or severe functional abnormality on the Qualification Echo, unless deemed not clinical relevant by the Investigator and approved by the Sponsor in writing;
• Ejection fraction (EF, estimated from Qualification Echo) =55% (outside normal range);
• Oxygen saturation <92% at rest;
• Females who are pregnant or lactating;
• A history or clinical manifestations of significant mental illness or significant pulmonary, hematological, renal, hepatic, central nervous, cardiovascular, genitourinary, or gastrointestinal disorders, or diabetes;
• A history of any major surgical procedure within 90 days of Screening/Baseline;
• Body mass index (BMI) >35;
• Inadequate visualization of 3 or more segments in the 4-chamber apical view for evaluation of cardiac function during the Qualification Echo;
• Sitting systolic blood pressure <90 mmHg or >150 mmHg, diastolic blood pressure <50 mmHg or >95 mmHg, pulse rate <45 bpm or >90 bpm;
• Frequent PVCs or PACs (defined as >5 PVCs and/or PACs per minute);
• Any =2nd AV block, bundle branch block (BBB), or rhythm abnormality;
• History of non-seasonal asthma within the past 3 years or a recent history of seasonal asthma requiring prescription medications to control;
• Participated in a clinical study involving an investigational drug or device within 30 days prior to AI-700 administration (90 days for subjects in the UK);
• Previous participation in an AI-700 clinical trial
Exclusion Criteria – Stable Cardiac Patients
• Any clinically unstable condition documented within 30 days prior to AI-700 administration or at Screening/Baseline. These conditions include, but are not limited to: severe arterial hypertension (systolic blood pressure >200 mmHg or diastolic blood pressure >120 mmHg) or pulmonary hypertension (>60 mmHg systolic), or any increase in pulmonary pressures felt to be due to increased pulmonary vascular resistance; hypotension (sitting systolic blood pressure <90 mmHg, diastolic blood pressure <50 mmHg); bradycardia or tachycardia (pulse rate <45 bpm or >100 bpm); history of any major surgical procedure; or exacerbation of chronic obstructive pulmonary disease (COPD) of any severity, irrespective of hospitalization.
• Recent history (past 6 months) of typical or atypical chest pain (angina), or unstable angina;
• Congestive heart failure (CHF) graded as New York Heart Association Class 3 or 4 within 90 days of dosing;
• COPD, with FEV1<50% of predicted, FEV1/FVC<75% of predicted, measured within 6 months prior to dosing;
• Significant left main coronary artery disease (=50% stenosis), if known;
• Any revascularization procedure within 90 days prior to AI-700 administration;
• Female who is pregnant or lactating;
• Cerebrovascular accident or transient ischemic attack within 90 days prior to AI-700 administration;
• Significant cardiovascular structural abnormality, including intra-cardiac shunts; uncorrected congenital heart disease (i.e., patent foramen ovale); idiopathic, severe valvul
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method