A Phase 3b, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Caffeine Intake on Single Photon Emission Computed Tomography (SPECT) Myocardial Perfusion Imaging (MPI) in Subjects Administered Regadenoson
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 347
- 主要终点
- Change in Number of Reversible Defects
研究概览
简要总结
Observe whether the administration of caffeine prior to regadenoson will affect the interpretation of test results in subjects with coronary artery disease (CAD) undergoing SPECT MPI
详细描述
All subjects will undergo rest and stress scans. Those subjects who qualify by demonstrating at least 1 reversible defect, will undergo a third scan. All stress scans will involve the injection of regadenoson as the pharmacologic stress agent. Prior to the third scan, the subject will be administered blinded capsules of placebo or caffeine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Subject must have undergone a previous diagnostic study [e.g., SPECT, echocardiography, magnetic resonance imaging (MRI), etc.] for a clinical indication demonstrating evidence of reversible defects in ≥ 1 vascular segment, have had other stress testing within the past 3 months, or the subject's history suggests at least a 50% likelihood of CAD
- •If the previous diagnostic study shows only 1 reversible defect and it is in segment 17, another reversible defect will need to be present
- •Subject with CAD must have an intermediate/low-risk for immediate intervention
- •Subject must ingest caffeinated food or beverages regularly (at least the equivalent of one cup of caffeinated coffee daily)
- •Subject must agree to not ingest any caffeine or other foods containing methylxanthine at least 24 hours prior to each study visit
- •Subject must agree to abstain from eating solid food or drinking liquids other than water for at least 30 minutes prior to each study visit and 30 minutes following each study visit
排除标准
- •Subject with documented myocardial infarction (MI) ≤ 30 days prior to enrollment
- •Subject with history of percutaneous coronary intervention (PCI) ≤ 4 weeks prior to enrollment
- •Subject with history of coronary artery bypass graft (CABG) ≤ 8 weeks prior to enrollment
- •Subject has prior history of heart transplantation
- •Subject has unstable angina, known severe left main coronary artery stenosis, severe heart failure, uncontrolled arrhythmias, symptomatic hypotension or severe hypertension (systolic blood pressure < 90 or > 180 mmHg, respectively), or > 1st degree atrioventricular block in the absence of a functioning pacemaker
- •Subject requires emergent cardiac medical intervention or catheterization
- •Subject has a history of smoking, regardless of frequency, tobacco type or method of intake, or using any smoking cessation products, including but not limited to the nicotine patch or nicotine gum, within 3 months prior to first dose of regadenoson
- •Subject is currently undergoing treatment with theophylline, or theophylline containing medications within 7 days prior to randomization (Day 3)
- •Subject has a history of known or suspected bronchoconstrictive or bronchospastic lung disease [e.g., asthma, wheezing, chronic obstructive pulmonary disease (COPD), etc.]
- •Subject has a history of diabetes associated with gastric disorders and/or emptying
- •Subject has end stage renal disease (ESRD) with a GFR< 15mL/min or currently undergoing dialysis for ESRD
研究组 & 干预措施
Placebo plus Regadenoson
Two placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
干预措施: regadenoson (Drug)
Placebo plus Regadenoson
Two placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
干预措施: technetium (Radiation)
Placebo plus Regadenoson
Two placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
干预措施: placebo (Drug)
Caffeine 200 mg plus Regadenoson
One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
干预措施: regadenoson (Drug)
Caffeine 200 mg plus Regadenoson
One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
干预措施: overencapsulated caffeine (Drug)
Caffeine 200 mg plus Regadenoson
One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
干预措施: technetium (Radiation)
Caffeine 400 mg plus Regadenoson
Two 200 mg Caffeine capsules plus 0.4 mg regadenoson per 5mL intravenous bolus injection
干预措施: regadenoson (Drug)
Caffeine 400 mg plus Regadenoson
Two 200 mg Caffeine capsules plus 0.4 mg regadenoson per 5mL intravenous bolus injection
干预措施: overencapsulated caffeine (Drug)
Caffeine 400 mg plus Regadenoson
Two 200 mg Caffeine capsules plus 0.4 mg regadenoson per 5mL intravenous bolus injection
干预措施: technetium (Radiation)
结局指标
主要结局
Change in Number of Reversible Defects
时间窗: Day 3 and Day 5
Each segment of the 17-Segment Model was assessed for radiotracer uptake on a scale of 0 (normal uptake) to 4 (absent uptake). Segments were counted as having a reversible defect if the stress score was greater than the rest score and the stress score was ≥ 2. Change was calculated as the number of reversible defects using regadenoson with caffeine/placebo (Day 5) minus the number of reversible defects using regadenoson alone (Day 3).
次要结局
- Change in Summed Difference Score (SDS) Across All 17 Segments(Day 3 and Day 5)
- Change in Number of Reversible Defects Assessed by Computerized Quantitation(Day 3 and Day 5)
- Change in Summed Difference Score Across All 17 Segments Assessed by Computerized Quantitation(Day 3 and Day 5)
- Change From Baseline in Heart Rate(Baseline, Day 5 (-3 min), Day 5 (+3 min), Day 5 (+15 min))
- Change From Baseline in Systolic Blood Pressure(Baseline, Day 5 (-3 min), Day 5 (+3 min), Day 5 (+15 min))
- Change From Baseline in Diastolic Blood Pressure(Baseline, Day 5 (-3 min), Day 5 (+3 min), Day 5 (+15 min))