NL-OMON31731已完成3 期
A phase III study to compare SonoVue® enhanced myocardial echocardiography (MCE) to single photon emission computerized tomography (ECG-GATED SPECT), at rest and at peak of low-dose Dipyridamole stress test, in the assessment of significant coronary artery disease (CAD) in patients with suspect or known CAD using Coronary Angiography as Gold Standard - BR1-125
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Having at least 18 years of age.
- •* Having a known or suspected coronary artery disease (CAD) indicated for stress ECGgated SPECT and/or coronary angiography to clarify whether they have a clinical
- •significant coronary stenosis (*70%).
- •* Having provided written Informed Consent and willing to comply with protocol
- •requirements.
排除标准
- •Has any clinically unstable cardiac condition prior to SonoVue® administration such as:
- •- evolving or ongoing myocardial infarction,
- •- a history of acute myocardial infarction or PCI within the previous 3 months,
- •- worsening of typical angina at rest within the previous 7 days,
- •- significant worsening of cardiac symptoms within the previous 7 days,
- •- recent coronary artery intervention or other factors suggesting clinical instability
- •(e.g., recent deterioration of ECG, laboratory or clinical findings),
- •- acute cardiac failure, class III/IV cardiac failure,
- •- severe cardiac rhythm disorders (ventricular tachycardia sustained and not sustained in combination with symptoms).
- •* Has any contra-indications to dipyridamole or aminophylline (e.g. hypersensitivity to xanthines) according to each agent*s package insert.
- •* Has any known allergy to one or more of the ingredients of the investigational product.
- •* Has a previous Coronary Artery By-pass.
- •* Has any revascularization procedure or change of clinical status that may warrant a change in their status of CAD among the clinical testing under evaluation (coronary angiography, MCE or ECG-GATED SPECT).
- •* Has used methylated xanthines (chocolate, caffeine * including coffee, tea, and cola drinks), phosphodiesterase inhibitor drugs such as aminophylline or dipyridamole within 24 hours prior SonoVue® enhanced echocardiography or SPECT.
- •* Has not visualization of left ventricle at basal echocardiography.
- •* Has received an investigational compound within 30 days before admission into this study.
- •* Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post dose follow-up examinations.
- •* Is determined by the Investigator that the subject is clinically unsuitable for the study.
- •* Is a pregnant or lactating female. Exclude the possibility of pregnancy:
- •* by testing on site at the institution (serum or urine *HCG) within 24 hours prior to the start of investigational product administration,
- •- by surgical history (e.g., tubal ligation or hysterectomy),
- •- post menopausal with a minimum 1 year without menses.
研究者
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