Trial · NCT00826280
Caffeine's Effect on Regadenoson Administration With Single Photon Emission Computed Tomography (SPECT) Myocardial Perfusion Imaging (MPI)
NCT00826280, Phase 3, Completed, Astellas Pharma Inc; results first posted 2011-10-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Caffeine's Effect on Regadenoson Administration With Single Photon Emission Computed Tomography (SPECT) Myocardial Perfusion Imaging (MPI). Trials, record NCT00826280. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00826280
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Caffeine's Effect on Regadenoson Administration With Single Photon Emission Computed Tomography (SPECT) Myocardial Perfusion Imaging (MPI)
- NCT number
- NCT00826280
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 347 participants, actual
- Lead sponsor
- Astellas Pharma Inc
- Conditions
- Coronary Artery Disease (CAD)
- Interventions
- regadenoson, overencapsulated caffeine, technetium, placebo
- First posted
- 2009-01-22
- Last updated
- 2024-12-03
- Results first posted
- 2011-10-21
- 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.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Number of Reversible Defects | 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). |
| Secondary | Change in Summed Difference Score (SDS) Across All 17 Segments | 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). |
| Secondary | Change in Number of Reversible Defects Assessed by Computerized Quantitation | 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). |
| Secondary | Change in Summed Difference Score Across All 17 Segments Assessed by Computerized Quantitation | 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). |
| Secondary | Change From Baseline in Heart Rate | 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. |
| Secondary | Change From Baseline in Systolic Blood Pressure | 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. |
| Secondary | Change From Baseline in Diastolic Blood Pressure | 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. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Number of Reversible Defects | Day 3 and Day 5 | The number of participants analyzed represents Full Analysis Set (FAS), which included all randomized subjects with interpretable Myocardial Perfusion Imaging (MPI) scans. The number of participants per arm is consistent for all categories of the data table. | Reversible Defects | MEAN |
| SECONDARY | Change in Summed Difference Score (SDS) Across All 17 Segments | Day 3 and Day 5 | The number of participants analyzed represents Full Analysis Set (FAS), which included all randomized subjects with interpretable MPI scans. The number of participants per arm is consistent for all categories of the data table. | Sum Difference Score | MEAN |
| SECONDARY | Change in Number of Reversible Defects Assessed by Computerized Quantitation | Day 3 and Day 5 | The number of participants analyzed per arm represents Full Analysis Set (FAS), all randomized subjects with interpretable MPI scans. The number of participants included in the calculation for each visit is noted in the category titles, as N. | Reversible Defects | MEAN |
| SECONDARY | Change in Summed Difference Score Across All 17 Segments Assessed by Computerized Quantitation | Day 3 and Day 5 | The number of participants analyzed per arm represents Full Analysis Set (FAS), all randomized subjects with interpretable MPI scans. The number of participants included in the calculation for each visit is noted in the category titles, as N. | Summed Difference Score | MEAN |
| SECONDARY | Change From Baseline in Heart Rate | Baseline, Day 5 (-3 min), Day 5 (+3 min), Day 5 (+15 min) | The number of participants analyzed per arm represents Safety Analysis Set (SAF) all randomized patients who received at least one dose of regadenoson. The number of participants included in the calculation for each visit is noted in the category titles, as N. | Beats per minute | MEDIAN |
| SECONDARY | Change From Baseline in Systolic Blood Pressure | Baseline, Day 5 (-3 min), Day 5 (+3 min), Day 5 (+15 min) | The number of participants analyzed per arm represents Safety Analysis Set (SAF) all randomized patients who received at least one dose of regadenoson. The number of participants included in the calculation for each visit is noted in the category titles, as N. | mmHg | MEDIAN |
| SECONDARY | Change From Baseline in Diastolic Blood Pressure | Baseline, Day 5 (-3 min), Day 5 (+3 min), Day 5 (+15 min) | The number of participants analyzed per arm represents Safety Analysis Set (SAF) all randomized patients who received at least one dose of regadenoson. The number of participants included in the calculation for each visit is noted in the category titles, as N. | mmHg | MEDIAN |
Source ClinicalTrials.gov
Results by group72
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Number of Reversible Defects | Placebo Plus Regadenoson | Baseline Stress Scan (Day 3) | 0.67 | Standard Deviation 1.377 | Reversible Defects |
| Change in Number of Reversible Defects | Caffeine 200 mg Plus Regadenoson | Baseline Stress Scan (Day 3) | 1.01 | Standard Deviation 1.452 | Reversible Defects |
| Change in Number of Reversible Defects | Caffeine 400 mg Plus Regadenoson | Baseline Stress Scan (Day 3) | 1.00 | Standard Deviation 1.595 | Reversible Defects |
| Change in Number of Reversible Defects | Placebo Plus Regadenoson | Double-Blind Stress Scan (Day 5) | 0.80 | Standard Deviation 1.511 | Reversible Defects |
| Change in Number of Reversible Defects | Caffeine 200 mg Plus Regadenoson | Double-Blind Stress Scan (Day 5) | 0.40 | Standard Deviation 0.907 | Reversible Defects |
| Change in Number of Reversible Defects | Caffeine 400 mg Plus Regadenoson | Double-Blind Stress Scan (Day 5) | 0.38 | Standard Deviation 0.962 | Reversible Defects |
| Change in Number of Reversible Defects | Placebo Plus Regadenoson | DoubleBlind - Baseline (Day 5 - Day 3) | 0.12 | Standard Deviation 0.981 | Reversible Defects |
| Change in Number of Reversible Defects | Caffeine 200 mg Plus Regadenoson | DoubleBlind - Baseline (Day 5 - Day 3) | -0.61 | Standard Deviation 1.097 | Reversible Defects |
| Change in Number of Reversible Defects | Caffeine 400 mg Plus Regadenoson | DoubleBlind - Baseline (Day 5 - Day 3) | -0.62 | Standard Deviation 1.367 | Reversible Defects |
| Change in Summed Difference Score (SDS) Across All 17 Segments | Placebo Plus Regadenoson | Baseline Stress Scan (Day 3) | 2.24 | Standard Deviation 3.013 | Sum Difference Score |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo Plus Regadenoson | 114 | |
| Overall Study | STARTED | Caffeine 200 mg Plus Regadenoson | 116 | |
| Overall Study | STARTED | Caffeine 400 mg Plus Regadenoson | 117 | |
| Overall Study | Safety Analysis Set | Placebo Plus Regadenoson | 113 | |
| Overall Study | Safety Analysis Set | Caffeine 200 mg Plus Regadenoson | 116 | |
| Overall Study | Safety Analysis Set | Caffeine 400 mg Plus Regadenoson | 116 | |
| Overall Study | Completed Treatment | Placebo Plus Regadenoson | 66 | |
| Overall Study | Completed Treatment | Caffeine 200 mg Plus Regadenoson | 71 | |
| Overall Study | Completed Treatment | Caffeine 400 mg Plus Regadenoson | 72 | |
| Overall Study | COMPLETED | Placebo Plus Regadenoson | 66 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events51
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal discomfort | Gastrointestinal disorders | Placebo Plus Regadenoson | 6 | 113 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Caffeine 200 mg Plus Regadenoson | 3 | 116 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Caffeine 400 mg Plus Regadenoson | 5 | 116 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo Plus Regadenoson | 6 | 113 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Caffeine 200 mg Plus Regadenoson | 4 | 116 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Caffeine 400 mg Plus Regadenoson | 5 | 116 | |
| other | Nausea | Gastrointestinal disorders | Placebo Plus Regadenoson | 13 | 113 | |
| other | Nausea | Gastrointestinal disorders | Caffeine 200 mg Plus Regadenoson | 16 | 116 | |
| other | Nausea | Gastrointestinal disorders | Caffeine 400 mg Plus Regadenoson | 10 | 116 | |
| other | Stomach discomfort | Gastrointestinal disorders | Placebo Plus Regadenoson | 7 | 113 |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo Plus Regadenoson | ||
| Total, all-cause mortality | Caffeine 200 mg Plus Regadenoson | ||
| Total, all-cause mortality | Caffeine 400 mg Plus Regadenoson | ||
| Total, other adverse events | Placebo Plus Regadenoson | 82 | 113 |
| Total, other adverse events | Caffeine 200 mg Plus Regadenoson | 89 | 116 |
| Total, other adverse events | Caffeine 400 mg Plus Regadenoson | 80 | 116 |
| Total, serious adverse events | Placebo Plus Regadenoson | 1 | 113 |
| Total, serious adverse events | Caffeine 200 mg Plus Regadenoson | 2 | 116 |
| Total, serious adverse events | Caffeine 400 mg Plus Regadenoson | 2 | 116 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21082298 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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Read this trial from software.
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