Phase 2
N=124
A Study of Regadenoson in Subjects Undergoing Stress Myocardial Perfusion Imaging (MPI) Using Multidetector Computed Tomography (MDCT) Compared to Single Photon Emission Computed Tomography (SPECT)
Coronary Artery Disease (CAD)
Bottom Line
View on ClinicalTrials.gov: NCT01334918 ↗Enrolled (actual)
124
Serious AEs
0.4%
Results posted
Sep 2013
Primary outcome: Primary: Number of Participants With Reversible Defects — 84; 16; 100; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- regadenoson (Drug); technetium Tc99m sestamibi /technetium Tc99m tetrafosmin (Radiation); Contrast (Radiation); Single Photon Emission Computed Tomography (Procedure); Multidetector Computed Tomography (Procedure)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- Astellas Pharma Inc
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Reversible Defects |
84; 16; 100; 1; 9; 10 | — |
| SECONDARY Overall Image Quality of Scans by Modality and Reviewer |
89; 25; 83; 30; 40; 56 | — |
| SECONDARY Number of Participants With Reversible Defects in the Left Anterior Descending Coronary Artery (LAD) |
90; 11; 101; 0; 4; 4 | — |
| SECONDARY Number of Participants With Reversible Defects in the Right Coronary Artery (RCA) |
92; 5; 97; 1; 0; 1 | — |
| SECONDARY Number of Participants With Reversible Defects in the Left Circumflex Coronary Artery (LCX) |
90; 9; 99; 2; 4; 6 | — |
| SECONDARY Number of Participants With Fixed Defects |
92; 5; 97; 3; 10; 13 | — |
| SECONDARY Percentage of Participants With Two or More Ischemic Segments on SPECT, But Less on CT |
10 | — |
Summary
The purpose of this study is to compare Multidetector Computed Tomography (MDCT) and Single Photon Emission Computed Tomography (SPECT) stress myocardial perfusion imaging (MPI) with regadenoson in order to detect the presence or absence of reversible defects.
Eligibility Criteria
Inclusion Criteria
- Male subjects must be ≥ 45 years of age
- Female subjects must be ≥ 50 years of age
- Subject has met at least one of the following three criteria:
- has a suspected (clinical impression) or known diagnosis of coronary artery disease (CAD) with typical angina that has been referred from nuclear cardiology lab schedule or cardiac computed tomography (CT) schedule
- has stable symptoms with possible elective catheterization procedure scheduled and where further imaging may be beneficial;
- has known CAD from a previous invasive coronary angiography (ICA) performed more than 12 weeks prior to screening who now present with new cardiac symptoms
- Subject has been referred for a clinically indicated myocardial perfusion imaging procedure or Cardiac CT procedure for suspected moderate or high risk CAD
- Subject must abstain from eating and drinking 30 minutes prior and 30 minutes post study drug administration
- Subject must abstain from smoking 3 hours prior and 8 hours post study drug administration
- Subject must abstain from any intake of methylxanthine-containing foods and beverages within 12 hours prior to Day 1 visit through the Day 3 Follow-Up Visit, as these foods may alter regadenoson effects. Subject is able to safely abstain from theophylline use for 12 hours prior to study drug administration
Exclusion Criteria
- Subject is concurrently participating in another drug study or has received an investigational drug within 30 days prior to Screening
- Subject has a history of a clinically significant illness (other than CAD), medical condition, or laboratory abnormality, which would preclude participation in the study
- Subject has renal dysfunction demonstrated by a glomerular filtration rate (GFR) 65 beats per minute) and contra-indications to administer beta-blockers (severe chronic obstructive pulmonary disease (COPD) or asthma, second and third degree atrioventricular block)
Data sourced from ClinicalTrials.gov (NCT01334918). 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.