Caffeine's Effect on Regadenoson Administration With Single Photon Emission Computed Tomography (SPECT) Myocardial Perfusion Imaging (MPI)
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
1 other identifier
interventional
347
1 country
25
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2009
Shorter than P25 for phase_3
25 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
January 21, 2009
CompletedFirst Posted
Study publicly available on registry
January 22, 2009
CompletedStudy Start
First participant enrolled
March 24, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 15, 2010
CompletedResults Posted
Study results publicly available
October 21, 2011
CompletedDecember 3, 2024
November 1, 2024
1.3 years
January 21, 2009
July 8, 2011
November 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Number of Reversible Defects
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).
Day 3 and Day 5
Secondary Outcomes (6)
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)
- +1 more secondary outcomes
Study Arms (3)
Placebo plus Regadenoson
PLACEBO COMPARATORTwo placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
Caffeine 200 mg plus Regadenoson
EXPERIMENTALOne 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
Caffeine 400 mg plus Regadenoson
EXPERIMENTALTwo 200 mg Caffeine capsules plus 0.4 mg regadenoson per 5mL intravenous bolus injection
Interventions
IV
IV
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Unknown Facility
Birmingham, Alabama, 35294, United States
Unknown Facility
Huntsville, Alabama, 35801, United States
Unknown Facility
La Mesa, California, 91942, United States
Unknown Facility
Mission Viejo, California, 92691, United States
Unknown Facility
Roseville, California, 95661, United States
Unknown Facility
Sacramento, California, 95819, United States
Unknown Facility
Santa Rosa, California, 95405, United States
Unknown Facility
Hartford, Connecticut, 06102-5037, United States
Unknown Facility
Newark, Delaware, 19173, United States
Unknown Facility
Jacksonville, Florida, 32216, United States
Unknown Facility
Miami, Florida, 33173, United States
Unknown Facility
Tamarac, Florida, 33321, United States
Unknown Facility
Aurora, Illinois, 60504, United States
Unknown Facility
Overland Park, Kansas, 66209, United States
Unknown Facility
Auburn, Maine, 04210, United States
Unknown Facility
Pittsfield, Massachusetts, 01201, United States
Unknown Facility
Detroit, Michigan, 48202, United States
Unknown Facility
Ypsilanti, Michigan, 48197, United States
Unknown Facility
Kansas City, Missouri, 64111, United States
Unknown Facility
Albany, New York, 12205, United States
Unknown Facility
Rochester, New York, 14642-8679, United States
Unknown Facility
Columbus, Ohio, 43214, United States
Unknown Facility
Philadelphia, Pennsylvania, 19102, United States
Unknown Facility
Wyomissing, Pennsylvania, 19610, United States
Unknown Facility
Knoxville, Tennessee, 37920, United States
Related Publications (1)
Tejani FH, Thompson RC, Iskandrian AE, McNutt BE, Franks B. Effect of caffeine on SPECT myocardial perfusion imaging during regadenoson pharmacologic stress: rationale and design of a prospective, randomized, multicenter study. J Nucl Cardiol. 2011 Feb;18(1):73-81. doi: 10.1007/s12350-010-9311-6. Epub 2010 Nov 17.
PMID: 21082298DERIVED
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
- Organization
- Astellas Pharma Global Development
Study Officials
- STUDY DIRECTOR
Use Central Contact
Astellas Pharma Global Development
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2009
First Posted
January 22, 2009
Study Start
March 24, 2009
Primary Completion
July 15, 2010
Study Completion
July 15, 2010
Last Updated
December 3, 2024
Results First Posted
October 21, 2011
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/.