Phase 3
N=1,147
A 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)
Coronary Artery Disease (CAD)
Bottom Line
View on ClinicalTrials.gov: NCT01618669 ↗Enrolled (actual)
1,147
Serious AEs
0.4%
Results posted
Feb 2016
Primary outcome: Primary: Proportion of Participants With Majority Reader Self-agreement in Ischemia Assessment Between First and Second Stress Scans — 0.92; 0.95 proportion of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Regadenoson (Drug); Single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Astellas Pharma Global Development, Inc.
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants With Majority Reader Self-agreement in Ischemia Assessment Between First and Second Stress Scans |
0.92; 0.95 | — |
| SECONDARY Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events |
3.0; 0.9; 0.5; 0.4; 2.8; 0.9 | — |
| SECONDARY Proportion of Participants With Agreement in the Assessment of Absence or Presence of Ischemia Between First and Second Stress Scans |
0.75; 0.77 | — |
| SECONDARY Proportion of Participants With Agreement in the Assessment of Reversible Defects in 3 Categories of Ischemia Between First and Second Stress Scans |
0.73; 0.75 | — |
| SECONDARY Proportion of Participants With Agreement in the Summed Stress Score (SSS) Between First and Second Stress Scans |
0.86; 0.84 | — |
| SECONDARY Proportion of Participants With Agreement in the Summed Difference Score (SDS) Between First and Second Stress Scans |
531; 4; 0; 527; 3; 0 | — |
| SECONDARY Participants With Less, the Same, or More Reversible Perfusion Defects Shown by the First Stress Scan When Compared to the Second Stress Scan |
57; 49; 441; 459; 40; 27 | — |
| SECONDARY Overall Assessment of Image Quality |
140; 157; 307; 308; 91; 70 | — |
| SECONDARY Target to Background Radiotracer Uptake Ratios From the First and Second Stress Scans |
1.05; 0.94; 0.96; 0.95; 1.12; 0.99 | — |
| SECONDARY Percentage of Scans With Subdiaphragmatic Interference |
0.4; 0.0; 0.0; 0.0; 71.8; 63.7 | — |
| SECONDARY Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Number of Participants With Adverse Events Within 24 Hours After Administration of Regadenoson |
302; 317; 329; 323; 291; 298 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01618669). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.