EUCTR2021-006295-17-DK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 - RAPID-WATER-FLOW
MedTrace Pharma0 个研究点目标入组 215 人开始时间: 2022年1月27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
- 215
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
- 性别
- All
入选标准
- •1.Male and female subjects =18 years;
- •2.Informed consent form (ICF) read, signed, and dated prior to any study procedures being performed;
- •3.Subjects who fall into any one of the following categories:
- •a)Have been referred for an ICA directly 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 assessment was performed.
- •c)Had a CCTA with normal coronaries or minimal CAD (Less than < 20% stenosis).
- •The PET 15O-H2O study and ICA or CCTA testing need to be completed within a 30-day window, with time 0 defined as the date of the first of
- •these three tests, or the screening visit for Pathway 1.
- •4.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 on the day of drug administration) must be negative;
- •these patients 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.
- •5.Male will need to use contraceptive methods until end of the follow-up period.
- •6.Patients are able to comply with all study procedures as described in the protocol.
- •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 130
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 85
排除标准
- •1.Subjects are unable to undergo (even partially) any of the imaging procedures;
- •2.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
- •3.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.
- •d. moderate or sever aortic or mitral stenosis or regurgitation.
- •4.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).
- •5.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.
- •6.Subjects with significant co-morbidities that would prevent appropriate completion of the
- •protocol procedures.
- •7.Subjects who have participated in another research study using investigational drugs within the 30
- •days prior to enrollment (Day 0) or through the duration of the trial (subjects in observational studies with approved agents and
- •subjects known to be on placebo may be enrolled).
- •8.Subjects who have previously participated in this study.
- •9.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
- •10.Subjects scheduled for, or planning to undergo, any interventional cardiac procedures between enrolment and ICA (pathway 1) signing of informed consent (IC) or enrolment and 15O-H2O
- •PET MPI (pathway 2 and 3)
研究者
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