CTIS2023-503843-33-00进行中（未招募）1 期
A Phase 3, Multicenter, Open Label Study to Confirm the Diagnostic Potential of Intravenously Administered 15O- H2O to Identify Coronary Artery Disease During Pharmacological Stress and Resting Conditions Using PET Imaging - MedTrace-002
MedTrace Pharma A/S0 个研究点目标入组 240 人开始时间: 2023年4月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 240
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 65+（—）
- 性别
- All
入选标准
- •Male and female subjects =18 years;, Informed consent form (ICF) read, signed, and dated prior to any study procedures being performed;, Subjects who fall into any one of the following categories: a. Have been referred for an ICA directly or after non-invasive testing (e.g., SPECT or PET MPI, stress echo, CCTA, ETT). b. Had an ICA with no intervention. However, if any stenosis >40% but =70% was observed, an FFR or iFR assessment was performed. c. Had a CCTA with normal coronaries or minimal CAD (less than < 20% stenosis )., Women of Child Bearing Potential (WOCBP) must be non-pregnant, and non-lactating. For women of childbearing potential, the results of a urine human chorionic gonadotropin (HCG) pregnancy test (with the result known prior to drug administration) must be negative; these subjects must be practicing appropriate birth control from time of the screening until end of the follow-up period. For women who are either surgically sterile (have a documented bilateral tubal ligation or oophorectomy and/or hysterectomy) or are post-menopausal (cessation of menses for more than 1 year), enrollment in the study without a pregnancy test at screening is allowed., Male will need to use contraceptive methods until end of the follow-up period., Subjects are able to comply with all study procedures as described in the protocol.
排除标准
- •Subjects are unable to undergo (even partially) any of the imaging procedures;, Subjects scheduled for, or planning to undergo, any interventional cardiac procedures between enrollment and ICA (pathway 1) or signing of informed consent and 15O-H2O PET MPI (pathway 2 and 3), Subjects with a known history of cardiac disease including: a. myocardial infarction, previous coronary revascularization, or chronic ischemic cardiomyopathy b. primary myocardial disease such as cardiac amyloidosis or hypertrophic cardiomyopathy c. known left ventricular dysfunction d. moderate or severe aortic or mitral stenosis or regurgitation, Subjects in whom adenosine stress testing is contraindicated, including but not limited to: a. Subjects with severe COPD or chronic asthma. b. Subjects with second- or third-degree atrioventricular block without a pacemaker., Subjects with claustrophobia to an extent that would limit their ability to undergo PET imaging (subjects whose claustrophobia is known to be readily controlled with drugs or psychological support may be enrolled)., Subjects who are on sildenafil (Viagra) or oral dipyridamole (Persantine, Aggrenox) therapy and for whom its use cannot be terminated or suspended for =24 hours prior to treatment of study drug., Subjects with significant co-morbidities that would prevent appropriate completion of the protocol procedures., Subjects who have participated in another research study using investigational drugs within the 30 days prior to enrollment or through the duration of the trial (subjects in observational studies with approved agents and subjects known to be on placebo may be enrolled)., Subjects who have previously participated in this study., Subjects with a close affiliation with the investigational site, defined as a close relative to the Investigator, or a dependent person such as an employee, student or intern at the investigational site.
研究者
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