A Phase 3, Multicenter, Open Label Study to Confirm the Diagnostic Potential of Intravenously Administered [15-O]-H2O to Identify Coronary Artery Disease During Pharmacological Stress and Resting Conditions Using PET Imaging (RAPID-WATER-FLOW)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 215
- 试验地点
- 21
- 主要终点
- Sensitivity and specificity of the [15-O]-H2O PET study using the truth-standard of ICA with FFR/iFR or CCTA.
研究概览
简要总结
This a Phase 3, prospective, open-label, multicenter study of [15-O]-H2O injection for PET imaging of subjects with suspected CAD. Approximately 182 evaluable participants with suspected CAD referred for testing will be included in the study at approximately 10 study sites in the United States and Europe. Approximately 215 participants will be enrolled to account for an estimated 15% drop-out rate. Screening assessments will occur prior to enrollment to confirm eligibility. All participants will receive two doses of [15-O]-H2O as part of a single PET imaging session (one dose at rest and one during pharmacological stress with adenosine). A safety follow-up phone call will occur 24 ± 8 hrs after completion of the [15-O]-H2O scan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Male and female participants ≥18 years;
- •Informed consent form (ICF) read, signed, and dated prior to any study procedures being performed;
- •Participants who fall into any one of the following categories:
- •Have been referred for an ICA directly of after non-invasive testing (e.g., SPECT or PET MPI, stress echo, CCTA, ETT).
- •Had an ICA with no intervention. However, if any stenosis >40% but ≤70% was observed, an FFR or iFR assessment was performed.
- •Had a CCTA with normal coronaries or minimal CAD (no stenosis >25%).
- •The SPECT study, 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.
- •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 participants must be practicing appropriate birth control from time of the screening visit until the 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.
- •Participants are able to comply with all study procedures as described in the protocol.
排除标准
- •Participants are unable to undergo (even partially) any of the imaging procedures;
- •Participants with a known history of cardiac disease including:
- •myocardial infarction, previous coronary revascularization, or chronic ischemic cardiomyopathy
- •primary myocardial disease such as cardiac amyloidosis or hypertrophic cardiomyopathy
- •known left ventricular dysfunction
- •moderate or severe aortic or mitral stenosis or regurgitation
- •Participants in whom adenosine stress testing is contraindicated, including but not limited to:
- •Participants with severe COPD or chronic asthma.
- •Participants with second- or third-degree atrioventricular block without a pacemaker.
- •Participants with claustrophobia to an extent that would limit their ability to undergo SPECT and PET imaging (patients whose claustrophobia is known to be readily controlled with drugs or psychological support may be enrolled).
- •Participants who are on sildenafil (Viagra) or oral dipyridamole (Persantine, Aggrenox) therapy or on any PDE5 inhibitor (i.e. tadalafil, avanafil, vardenafil),and for whom its use cannot be terminated or suspended for ≥24 hours prior to treatment of study drug.
- •Participants with significant co-morbidities that would prevent appropriate completion of the protocol procedures.
- •Participants who have participated in another research study using investigational drugs within the 30 days prior to enrollment or through the duration of the trial (patients in observational studies with approved agents and participants known to be on placebo may be enrolled).
- •Participants who have previously participated in this study.
- •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)
研究组 & 干预措施
[O-15]-Water PET Myocardial Perfusion Imaging (MPI)
All participants with suspected CAD will receive two doses of [15-O]-H2O as part of a single PET imaging session (one dose at rest and one during pharmacological stress with adenosine).
干预措施: [O-15]-Water PET Myocardial Perfusion Imaging (MPI) (Drug)
结局指标
主要结局
Sensitivity and specificity of the [15-O]-H2O PET study using the truth-standard of ICA with FFR/iFR or CCTA.
时间窗: 30 days
Sensitivity and specificity are defined as follows: * True Positives (TP): Subjects with abnormal PET MPI and disease positive by the truth standard * True Negatives (TN): Subjects with normal PET MPI and disease negative by the truth standard * False Positives (FP): Subjects with abnormal PET MPI and disease negative by the truth standard * False Negatives (FN): Subjects with normal PET MPI and disease positive by the truth standard * Sensitivity: TP/(TP + FN) * Specificity: TN/(TN + FP)
次要结局
- Sensitivity and specificity of 15O-H2O PET in subjects where the standard of truth may use site-determined value of FFR/iFR when the raw FFR/iFR data are not available to the core lab.(30 days)
- Sensitivity, specificity, and accuracy of [15-O]-H2O PET MPI in participants of special clinical interest (female, BMI≥30, diabetics, multivessel disease).(30 days)
- Adverse event analyses will include tabulations of the incidence (number and percent of subjects) with at least one TEAEs overall and by MedDRA system organ class (SOC) and preferred term (PT). This will be repeated for serious adverse.(30 days)