- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00826280
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35294
-
Huntsville, Alabama, United States, 35801
-
-
California
-
La Mesa, California, United States, 91942
-
Mission Viejo, California, United States, 92691
-
Roseville, California, United States, 95661
-
Sacramento, California, United States, 95819
-
Santa Rosa, California, United States, 95405
-
-
Connecticut
-
Hartford, Connecticut, United States, 06102-5037
-
-
Delaware
-
Newark, Delaware, United States, 19173
-
-
Florida
-
Jacksonville, Florida, United States, 32216
-
Miami, Florida, United States, 33173
-
Tamarac, Florida, United States, 33321
-
-
Illinois
-
Aurora, Illinois, United States, 60504
-
-
Kansas
-
Overland Park, Kansas, United States, 66209
-
-
Maine
-
Auburn, Maine, United States, 04210
-
-
Massachusetts
-
Pittsfield, Massachusetts, United States, 01201
-
-
Michigan
-
Detroit, Michigan, United States, 48202
-
Ypsilanti, Michigan, United States, 48197
-
-
Missouri
-
Kansas City, Missouri, United States, 64111
-
-
New York
-
Albany, New York, United States, 12205
-
Rochester, New York, United States, 14642-8679
-
-
Ohio
-
Columbus, Ohio, United States, 43214
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19102
-
Wyomissing, Pennsylvania, United States, 19610
-
-
Tennessee
-
Knoxville, Tennessee, United States, 37920
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo plus Regadenoson
Two placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
|
oral
IV
Other Names:
IV
Other Names:
|
EXPERIMENTAL: Caffeine 200 mg plus Regadenoson
One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
|
IV
Other Names:
IV
Other Names:
oral
|
EXPERIMENTAL: Caffeine 400 mg plus Regadenoson
Two 200 mg Caffeine capsules plus 0.4 mg regadenoson per 5mL intravenous bolus injection
|
IV
Other Names:
IV
Other Names:
oral
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Number of Reversible Defects
Time Frame: Day 3 and Day 5
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Summed Difference Score (SDS) Across All 17 Segments
Time Frame: Day 3 and Day 5
|
The Summed Difference Score was calculated as the difference in the Summed Stress Score across the 17 segments (scan run under stress condition) minus the Summed Rest Score across the 17 segments (scan run under rest conditions). Change in SDS was calculated as the SDS for regadenoson with caffeine/placebo stress scan (Day 5) minus the SDS for regadenoson only stress scan (Day 3). The full range of the SDS is -68 to 68, where 0 represents no change between Summed Stress Score and Summed Rest Score. A higher positive score indicates more severe coronary artery disease (CAD). |
Day 3 and Day 5
|
Change in Number of Reversible Defects Assessed by Computerized Quantitation
Time Frame: Day 3 and Day 5
|
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
|
Change in Summed Difference Score Across All 17 Segments Assessed by Computerized Quantitation
Time Frame: Day 3 and Day 5
|
The Summed Difference Score was calculated as the difference in the Summed Stress Score across the 17 segments (scan run under stress condition) minus the Summed Rest Score across the 17 segments (scan run under rest conditions). Change in SDS was calculated as the SDS for regadenoson with caffeine/placebo stress scan (Day 5) minus the SDS for regadenoson only stress scan (Day 3). The full range of the SDS is -68 to 68, where 0 represents no change between Summed Stress Score and Summed Rest Score. A higher positive score indicates more severe coronary artery disease (CAD). |
Day 3 and Day 5
|
Change From Baseline in Heart Rate
Time Frame: Baseline, Day 5 (-3 min), Day 5 (+3 min), Day 5 (+15 min)
|
Baseline is the last non-missing measurement on or before first dose of regadenoson Change is calculated as the time point minus baseline. |
Baseline, Day 5 (-3 min), Day 5 (+3 min), Day 5 (+15 min)
|
Change From Baseline in Systolic Blood Pressure
Time Frame: Baseline, Day 5 (-3 min), Day 5 (+3 min), Day 5 (+15 min)
|
Baseline is the last non-missing measurement on or before first dose of regadenoson. Change is calculated as the time point minus baseline. |
Baseline, Day 5 (-3 min), Day 5 (+3 min), Day 5 (+15 min)
|
Change From Baseline in Diastolic Blood Pressure
Time Frame: Baseline, Day 5 (-3 min), Day 5 (+3 min), Day 5 (+15 min)
|
Baseline is the last non-missing measurement on or before first dose of regadenoson. Change is calculated as the time point minus baseline. |
Baseline, Day 5 (-3 min), Day 5 (+3 min), Day 5 (+15 min)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Artery Disease
- Myocardial Ischemia
- Coronary Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Purinergic Antagonists
- Purinergic Agents
- Phosphodiesterase Inhibitors
- Purinergic P1 Receptor Antagonists
- Central Nervous System Stimulants
- Purinergic P1 Receptor Agonists
- Purinergic Agonists
- Adenosine A2 Receptor Agonists
- Caffeine
- Regadenoson
Other Study ID Numbers
- 3606-CL-3002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Coronary Artery Disease (CAD)
-
National Institutes of Health Clinical Center (CC)National Heart, Lung, and Blood Institute (NHLBI)CompletedCoronary Arteriosclerosis | Coronary Artery Disease (CAD) | Obstructive Coronary Artery DiseaseUnited States
-
Assiut UniversityRecruitingCAD - Coronary Artery DiseaseEgypt
-
Johann Wolfgang Goethe University HospitalActive, not recruiting
-
Sinotau Pharmaceutical GroupCompletedCoronary Artery Disease (CAD)China
-
GE HealthcareCompletedCoronary Artery Disease (CAD)United States
-
Eli Lilly and CompanyDaiichi Sankyo Co., Ltd.TerminatedCoronary Artery Disease (CAD)United States, Germany
-
Anthera PharmaceuticalsCompletedCoronary Artery Disease (CAD)United States, Ukraine
-
GE HealthcarePharmaceutical Product Development, LLCCompletedCoronary Artery Disease (CAD)United States, Germany, Switzerland, Canada, Netherlands, France, Finland
-
Columbia UniversityTerminatedCoronary Artery Disease (CAD)United States
-
The Medicines CompanyCompletedCoronary Artery Disease (CAD)United States
Clinical Trials on placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States