EUCTR2006-003012-21-GB进行中（未招募）1 期
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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •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
排除标准
- •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
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