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)
A Phase 2, Open-Label, Randomized, Cross-Over Study of Regadenoson in Subjects Undergoing Stress Myocardial Perfusion Imaging by Multidetector Computed Tomography (MDCT) and Single Photon Emission Computed Tomography (SPECT)
1 other identifier
interventional
124
1 country
11
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2011
Shorter than P25 for phase_2
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2011
CompletedFirst Posted
Study publicly available on registry
April 13, 2011
CompletedStudy Start
First participant enrolled
April 26, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 2, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 2, 2012
CompletedResults Posted
Study results publicly available
September 18, 2013
CompletedDecember 4, 2024
November 1, 2024
1.2 years
April 12, 2011
July 11, 2013
November 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Reversible Defects
The number of reversible defects categorized into absence or presence of ischemia (0-1 versus ≥2), as assessed by the central imaging laboratory for both SPECT and MDCT. The 17-segment model for standardized myocardial segmentation was used for myocardial perfusion readings for SPECT and MDCT. At rest and stress, each segment was scored on a 0 to 4 scale according to the amount of contrast or radiotracer the myocardium in the segment absorbed: -0: normal perfusion -1: slightly reduced contrast/radiotracer uptake -2: moderately reduced contrast/radiotracer uptake -3: severely reduced contrast/radiotracer uptake -4: absent contrast/radiotracer uptake. The median score from the 3 blinded readers for each segment was used. 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. A participant was classified as ischemic in the presence of 2 or more segments with reversible defects, excluding segment 17.
Day 1 and Day 2
Secondary Outcomes (6)
Overall Image Quality of Scans by Modality and Reviewer
Day 1 and Day 2
Number of Participants With Reversible Defects in the Left Anterior Descending Coronary Artery (LAD)
Day 1 and Day 2
Number of Participants With Reversible Defects in the Right Coronary Artery (RCA)
Day 1 and Day 2
Number of Participants With Reversible Defects in the Left Circumflex Coronary Artery (LCX)
Day 1 and Day 2
Number of Participants With Fixed Defects
Day 1 and Day 2
- +1 more secondary outcomes
Study Arms (2)
Single Photon Emission Computed Tomography (SPECT)
EXPERIMENTALResting SPECT imaging was performed prior to regadenoson stress SPECT imaging. Imaging was conducted with one of two radiotracers (99mTc sestamibi or tetrofosmin). Regadenoson 0.4 mg was administered prior to stress SPECT as a single bolus injection.
Multidetector Computed Tomography (MDCT)
EXPERIMENTALMultidetector Computed Tomography (MDCT), composed of CCTA and regadenoson CTP. Regadenoson stress CTP was performed prior to rest CCTA/CTP imaging. Regadenoson 0.4 mg was administered prior to stress CTP as a single bolus injection. The rest CCTA/CTP was performed at least 30 minutes after completion of the stress CTP, after resolution of any symptoms brought on by the regadenoson infusion and after the participant's heart rate had returned to baseline.
Interventions
Administered by intravenous bolus.
Administered by intravenous infusion
Administered by intravenous infusion.
Procedure/Surgery
Procedure/Surgery
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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) \< 45 mL/min (calculated using Cockroft-Gault formula Note: Subjects with a GFR 45-60 mL/min will undergo a hydration procedure
- Female subject who is pregnant, lactating or of childbearing potential that refuses to use a medically acceptable form of contraception until the Telephone Follow up Visit is complete
- Female subject has a positive pregnancy test prior to randomization
- Subject has a history of second or third degree heart block or sinus node dysfunction unless the subject has a functioning pacemaker
- Subject has symptomatic hypotension (temporary and reversible conditions that no longer exist are allowed)
- Subject is allergic or intolerant to aminophylline, nitroglycerin or metoprolol
- Subject is allergic or intolerant to regadenoson or any of its excipients
- Subject is unable or unwilling to comply with the procedure schedule
- Subject has previously enrolled in this study or was enrolled in another regadenoson study sponsored by Astellas
- Subject has atrial fibrillation or significant arrhythmias which may result in decreased image quality for the imaging studies (CT and SPECT)
- Subject has high heart rate (\> 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Sutter Roseville Medical Center
Roseville, California, 95661, United States
Harbor UCLA Medical Center
Torrance, California, 90502, United States
Cardiovascular Research Center of South Florida
Miami, Florida, 33173, United States
Baptist Hospital of Miami
Miami, Florida, 33176, United States
Midwest Cardiology Associates, P.C.
Overland Park, Kansas, 66029, United States
Maine Research Associates
Auburn, Maine, 04210, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Berkshire Medical Center
Pittsfield, Massachusetts, 01201, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Related Publications (1)
Cury RC, Kitt TM, Feaheny K, Akin J, George RT. Regadenoson-stress myocardial CT perfusion and single-photon emission CT: rationale, design, and acquisition methods of a prospective, multicenter, multivendor comparison. J Cardiovasc Comput Tomogr. 2014 Jan-Feb;8(1):2-12. doi: 10.1016/j.jcct.2013.09.004. Epub 2013 Oct 18.
PMID: 24314823DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Company makes no warranties or representations of any kind as to the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose, and shall not be liable for any damages.
Results Point of Contact
- Title
- Senior Medical Director, Medical Affairs
- Organization
- Astellas Scientific and Medical Affairs, Inc. / Astellas Pharma Global Development, Inc.
Study Officials
- STUDY DIRECTOR
Senior Medical Director
Astellas Pharma Global Development
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2011
First Posted
April 13, 2011
Study Start
April 26, 2011
Primary Completion
July 2, 2012
Study Completion
July 2, 2012
Last Updated
December 4, 2024
Results First Posted
September 18, 2013
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
- Access Criteria
- Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.