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The purpose of this study is to evaluate the consistency of quantitative peak stress myocardial blood flow and myocardial blood flow reserve following a 10 second, 1 minute, 2 minute or 4 minute delay in beginning the rubidium-82 infusion post-Lexiscan (regadenoson) injection. It is anticipated that there will be no or minimal difference between the four delay times.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10 Second Delay | Active Comparator | A 10 second delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging. |
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| 2 Minute Delay | Active Comparator | A 2 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging. |
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| 4 Minute Delay | Active Comparator | A 4 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging. |
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| 1 Minute Delay | Active Comparator | A 1 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regadenoson | Drug | Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. |
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| Measure | Description | Time Frame |
|---|---|---|
| Measure Quantitated Myocardial Perfusion Reserve After a 4 Minute Delay in Lexiscan (Regadenoson) | The end-point of this study is to establish the mean and standard deviations of myocardial blood flow reserve (peak stress to rest ratio) values based on a 10 second, 1 minute, 2 minute and 4 minute delays between Lexiscan (Regadenoson) injection and the start of myocardial perfusion PET imaging. | 4 minutes |
| Measure Quantitated Myocardial Perfusion Reserve After a 2 Minute Delay in Lexiscan (Regadenoson) | The end-point of this study is to establish the mean and standard deviations of myocardial blood flow reserve (peak stress to rest ratio) values based on a 10 second, 1 minute, 2 minute and 4 minute delays between Lexiscan (Regadenoson) injection and the start of myocardial perfusion PET imaging. | 2 mintues |
| Measure Quantitated Myocardial Perfusion Reserve After a 10 Second Delay in Lexiscan (Regadenoson) | The end-point of this study is to establish the mean and standard deviations of myocardial blood flow reserve (peak stress to rest ratio) values based on a 10 second, 1 minute, 2 minute and 4 minute delays between Lexiscan (Regadenoson) injection and the start of myocardial perfusion PET imaging. | 10 seconds |
| Measure Quantitated Myocardial Perfusion Reserve After a 1 Minute Delay in Lexiscan (Regadenoson) | The end-point of this study is to establish the mean and standard deviations of myocardial blood flow reserve (peak stress to rest ratio) values based on a 10 second, 1 minute, 2 minute and 4 minute delays between Lexiscan (Regadenoson) injection and the start of myocardial perfusion PET imaging. | 1 minute |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy M Bateman, MD | Cardiovascular Imaging Technologies | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Luke's Hospital Imaging Center | Kansas City | Missouri | 64111 | United States |
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Subjects with a low pretest likelihood for CAD based on gender, symptoms and recent (<90 days) normal-clinically-indicated TMET, exercise echocardiogram or exercise myocardial perfusion SPECT test were recruited for consent and participation.
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| ID | Title | Description |
|---|---|---|
| FG000 | 10 Second Delay | A 10 second delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging. Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Rubidium-82 | Radiation | Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. |
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| FG001 |
| 2 Minute Delay |
A 2 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging. Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. |
| FG002 | 4 Minute Delay | A 4 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging. Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. |
| FG003 | 1 Minute Delay | A 1 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging. Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 10 Second Delay | A 10 second delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging. Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. |
| BG001 | 2 Minute Delay | A 2 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging. Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. |
| BG002 | 4 Minute Delay | A 4 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging. Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. |
| BG003 | 1 Minute Delay | A 1 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging. Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Measure Quantitated Myocardial Perfusion Reserve After a 4 Minute Delay in Lexiscan (Regadenoson) | The end-point of this study is to establish the mean and standard deviations of myocardial blood flow reserve (peak stress to rest ratio) values based on a 10 second, 1 minute, 2 minute and 4 minute delays between Lexiscan (Regadenoson) injection and the start of myocardial perfusion PET imaging. | Posted | Mean | Standard Deviation | Ratio | 4 minutes |
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| Primary | Measure Quantitated Myocardial Perfusion Reserve After a 2 Minute Delay in Lexiscan (Regadenoson) | The end-point of this study is to establish the mean and standard deviations of myocardial blood flow reserve (peak stress to rest ratio) values based on a 10 second, 1 minute, 2 minute and 4 minute delays between Lexiscan (Regadenoson) injection and the start of myocardial perfusion PET imaging. | Posted | Mean | Standard Deviation | Ratio | 2 mintues |
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| Primary | Measure Quantitated Myocardial Perfusion Reserve After a 10 Second Delay in Lexiscan (Regadenoson) | The end-point of this study is to establish the mean and standard deviations of myocardial blood flow reserve (peak stress to rest ratio) values based on a 10 second, 1 minute, 2 minute and 4 minute delays between Lexiscan (Regadenoson) injection and the start of myocardial perfusion PET imaging. | Posted | Median | Standard Deviation | Ratio | 10 seconds |
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| Primary | Measure Quantitated Myocardial Perfusion Reserve After a 1 Minute Delay in Lexiscan (Regadenoson) | The end-point of this study is to establish the mean and standard deviations of myocardial blood flow reserve (peak stress to rest ratio) values based on a 10 second, 1 minute, 2 minute and 4 minute delays between Lexiscan (Regadenoson) injection and the start of myocardial perfusion PET imaging. | Posted | Mean | Standard Deviation | Ratio | 1 minute |
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Adverse events were collected immediately post-informed consent and through the patient's entire visit to the imaging facility.
AEs were recorded on an Adverse Event (AE) log. The AE log consisted of: 1.) Description of event; 2.) Start and stop time of event; 3.) Severity of event; 4.) Likelihood that the event was related to the study drug; 5.) Relationship of event to other test procedures; 6.) Any treatment actions taken, and 7.) the final outcome.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 10 Second Delay | A 10 second delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging. Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. | 0 | 20 | 0 | 20 | ||
| EG001 | 2 Minute Delay | A 2 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging. Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. | 0 | 20 | 0 | 20 | ||
| EG002 | 4 Minute Delay | A 4 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging. Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. | 0 | 19 | 0 | 19 | ||
| EG003 | 1 Minute Delay | A 1 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging. Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. | 1 | 20 | 0 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neck Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | 1 subject was admitted to ED 4 days post-study participation with chest/neck pain, predating study. Based upon symptoms and palpable left lateral neck discomfort, pt. was dismissed with a dx of musculoskeletal etiology. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Timothy M. Bateman, MD | Cardiovascular Imaging Technologies, LLC | 816-531-2842 | tbateman@cvit.com |
| ID | Term |
|---|---|
| C430916 | regadenoson |
| C000615479 | Rubidium-82 |
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| Male |
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