A Phase 3b, Open-Label, Parallel Group, Randomized, Multicenter Study to Assess Regadenoson Administration Following an Inadequate Exercise Stress Test as Compared to Regadenoson Alone for Myocardial Perfusion Imaging (MPI) Using Single Photon Emission Computed Tomography (SPECT)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,147
- 试验地点
- 69
- 主要终点
- Proportion of Participants With Majority Reader Self-agreement in Ischemia Assessment Between First and Second Stress Scans
研究概览
简要总结
The purpose of this study is to demonstrate that the strength of agreement between single photon emission computed tomography (SPECT) imaging with regadenoson following inadequate exercise stress testing and SPECT imaging with regadenoson alone is not inferior to the strength of agreement between two sequential regadenoson SPECT images without exercise.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Subjects referred for an exercise or pharmacologic stress test SPECT MPI procedure for the evaluation of coronary artery disease (CAD) are eligible for study participation. Subjects referred for pharmacologic stress should have a reasonable potential of attempting exercise stress. Subject must have one of the following:
- •a. Past ischemia on any prior imaging stress test without invasive intervention on the artery subtending this territory
- •b. Subject with known CAD who have symptoms similar to previous ischemic symptoms, or recent onset of symptoms or recently worsened symptoms suggestive of ischemia
- •c. Diamond Forrester estimated pretest probability of CAD of ≥ 50%
- •d. History of most recent coronary artery bypass surgery or most recent percutaneous coronary intervention (PCI) > 10 years (patients who are > 30 days but less than 10 years post coronary artery bypass graft (CABG) or PCI can be included if they meet criteria a, b, or e)
- •e. Previously demonstrated 100% occlusion by invasive coronary or computed tomography (CT) angiography without successful intervening revascularization as these foods may alter regadenoson effects
排除标准
- •Subject has a clinically significant illness, medical condition, or laboratory abnormality
- •Female subject who is pregnant or lactating
- •Subject is on dialysis for end stage renal disease or has a history of glomerular filtration rate (GFR) < 15 mL/min (calculated using MDRD [Modification of Diet in Renal Disease] formula)
- •Subject has a history of coronary revascularization by either PCI or CABG within 1 month prior to the rest myocardial perfusion imaging (MPI)
- •Subject has a pacemaker or an implantable cardioverter defibrillator (ICD)
- •Subject has a history of acute myocardial infarction (MI) or high risk unstable angina within 30 days prior to the rest MPI or has had cardiac transplantation
- •Subject has uncontrolled hypertension at any point on Visit 2 prior to exercise testing (i.e., systolic blood pressure (SBP) ≥ 180 or diastolic blood pressure (DBP) ≥ 95 mmHg on two consecutive measurements while at rest).
- •Subject has severe aortic stenosis or hypertrophic cardiomyopathy with obstruction or has decompensated congestive heart failure
- •Subject has a history of severe respiratory disease including: asthma, chronic obstructive pulmonary disease (COPD) or other bronchospastic reactive airway disease or who is on 24-hour continuous oxygen
研究组 & 干预措施
Regadenoson After Peak Exercise
On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
干预措施: Regadenoson (Drug)
Regadenoson After Peak Exercise
On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
干预措施: Single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) (Procedure)
Regadenoson Alone
On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus (1 hour after exercise recovery), and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
干预措施: Regadenoson (Drug)
Regadenoson Alone
On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus (1 hour after exercise recovery), and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
干预措施: Single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) (Procedure)
结局指标
主要结局
Proportion of Participants With Majority Reader Self-agreement in Ischemia Assessment Between First and Second Stress Scans
时间窗: Day 1 (rest scan and first stress scan) and Day 2 -15 (second stress scan)
SPECT scans were reviewed in a blinded fashion by 3 independent expert readers using the 17-segment model for standardized myocardial segmentation. At rest and stress, each segment was scored on a 0 (normal) to 4 (absent contrast/radiotracer uptake) scale by each of the 3 blinded readers according to the amount of contrast or radiotracer the myocardium in the segment absorbed. If the stress score was ≥ 2 and the rest score was less than the stress score, the segment was counted as having a reversible defect. The number of segments with reversible defects was categorized as absence (0 - 1 reversible segments) or presence (≥ 2 defects reversible segments) of ischemia. Each reader was defined as having self-agreement based upon identical categorization of a given participant as absent or present for ischemia for both the initial and second stress visits. Majority agreement is if at least 2 out of the 3 blinded readers demonstrated self-agreement for a given participant.
次要结局
- Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity(Day 1 (stress MPI 1) and Day - 15 (stress MPI 2))
- Proportion of Participants With Agreement in the Assessment of Absence or Presence of Ischemia Between First and Second Stress Scans(Day 1 (stress MPI 1) and Day 2 -15 (stress MPI 2))
- Participants With Less, the Same, or More Reversible Perfusion Defects Shown by the First Stress Scan When Compared to the Second Stress Scan(Day 1 (stress MPI 1) and Day 2-15 (stress MPI 2))
- Target to Background Radiotracer Uptake Ratios From the First and Second Stress Scans(Day 1 (stress MPI 1) and Day 2 - 15 (stress MPI 2))
- Percentage of Scans With Subdiaphragmatic Interference(Day 1 (stress MPI 1) and Day 2 -15 (stress MPI 2))
- Number of Participants With Adverse Events Within 24 Hours After Administration of Regadenoson(Up to 24 hours after study drug administration for each stress MPI (Day 1 and Day 2-15))
- Proportion of Participants With Agreement in the Assessment of Reversible Defects in 3 Categories of Ischemia Between First and Second Stress Scans(Day 1 (stress MPI 1) and Day 2 - 15 (stress MPI 2))
- Proportion of Participants With Agreement in the Summed Stress Score (SSS) Between First and Second Stress Scans(Day 1 (stress MPI 1) and Day 2 - 15 (stress MPI 2))
- Proportion of Participants With Agreement in the Summed Difference Score (SDS) Between First and Second Stress Scans(Day 1 (rest MPI and stress MPI 1) and Day 2 - 15 (stress MPI 2))
- Overall Assessment of Image Quality(Day 1 (rest MPI and stress MPI 1) and Day 2 - 15 (stress MPI 2))
- Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events(Within 1 hour for ECG events and up to 24 hours for adverse events after administration of regadenoson)