NCT00381316已完成4 期
Comparison of Diagnostic Rest/Stress SPECT Results for Patients With Myocardial Ischemia and Infarction Using Myoview in Both Single and Dual Isotope Acquisition Approaches
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 291
- 试验地点
- 1
- 主要终点
- The diagnostic results ("normal" versus "abnormal") of the dual-isotope and single isotope myocardial SPECT examinations will be compared for equivalence on a subject level for the Uninformed and Informed Analysis Groups.
研究概览
简要总结
The study is designed to determine whether a dual isotope protocol is equivalent to a single isotope in the diagnosis of myocardial ischemia and infarction using MYOVIEW SPECT imaging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is 18 years old or older.
- •Male subjects or non-lactating female subjects, who are either surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (cessation of menses for more than 1 year), or for women of childbearing potential, the results of a serum or urine human chorionic gonadotropin pregnancy test, performed at screening within 24 hours before dosing (with the result known before investigational medicinal product administration) must be negative.
- •The subject is able and willing to comply with study procedures (i.e., 1 SPECT imaging at Stress, 2 SPECT imagings at Rest) and signed and dated informed consent is obtained.
- •The subject is suspected of or known of having CAD based on the subject's clinical signs, symptoms, or examinations .
- •The subject is referred for Rest/Stress (exercise or pharmacological) MPS-SPECT for known or suspected CAD (as clinically required).
排除标准
- •The subject was previously included in this study.
- •The subject received an IMP within 30 days before or is scheduled to receive one during or in the next 30 days after IMP administration.
- •The subject has known allergies to any product used in this study or its constituents, including subjects who are not able to exercise and have contraindications to Adenosine (e.g., Asthmatics).
- •The subject presents any clinically active, serious, life-threatening disease, with a life expectancy of less than 1 month.
- •The subject has no contraindications to any of the study procedures (e.g. physical exercise) or the involved drugs (Myoview, Thallium-201, Adenosine or Dipyridamole) such as e.g. 2nd or 3rd degree AV-block, SS syndrome, bradycardia, bronchoconstrictive or bronchospastic lung disease.
研究组 & 干预措施
1
Active Comparator
Thallous Chloride T1-201
干预措施: Thallous Chloride T1-201 (Drug)
2
Active Comparator
Technetium Tc99m Tetrofosmin injections
干预措施: Technetium Tc99m Tetrofosmin injections (Drug)
结局指标
主要结局
The diagnostic results ("normal" versus "abnormal") of the dual-isotope and single isotope myocardial SPECT examinations will be compared for equivalence on a subject level for the Uninformed and Informed Analysis Groups.
次要结局
未报告次要终点
研究者
研究点 (1)
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