EUCTR2007-003492-39-GB进行中（未招募）1 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 - SonoVue® MCE vs SPECT
Bracco Research S.P.A0 个研究点目标入组 597 人开始时间: 2008年3月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 597
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
- •Include subjects of both sexes who fulfill all following inclusion criteria:
- •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.
- •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
- •Exclude a subject from this study if the subject does not fulfill the inclusion criteria, or if any of the following conditions are observed:
- •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 ßHCG) 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.
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