Myocardial Blood Flow Reserve
Conditions
Keywords
PET, Lexiscan, Regadenoson, Rubidium, Blood Flow Reserve, Myocardial Perfusion, Quantitated Myocardial Perfusion
Brief summary
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.
Interventions
DRUGRegadenoson
Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.
RADIATIONRubidium-82
Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.
Sponsors
Timothy M. Bateman, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Recent normal clinically-indicated exercise myocardial perfusion SPECT, treadmill maximal exercise test or exercise echocardiographic study * No change in symptoms between the exercise study and PET study * Capable of providing written informed consent * BMI 25-32 kg/m2
Exclusion criteria
* Diabetes mellitus * Coronary Artery Calcium Score \>25 * Second and Third Degree Atrioventricular Node Block * Sinus Node Dysfunction * Recent Syncope of unknown etiology * Left ventricular hypertrophy per ECG or echocardiography * Slowed circulation times * Active wheezing or with acute asthmatic or bronchospastic attacks requiring changes in therapy within the past 30 days. * Patients that have experienced a previous hypersensitivity reaction thought to be related to Lexiscan
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure Quantitated Myocardial Perfusion Reserve After a 4 Minute Delay in Lexiscan (Regadenoson) | 4 minutes | 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. |
| Measure Quantitated Myocardial Perfusion Reserve After a 2 Minute Delay in Lexiscan (Regadenoson) | 2 mintues | 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. |
| Measure Quantitated Myocardial Perfusion Reserve After a 10 Second Delay in Lexiscan (Regadenoson) | 10 seconds | 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. |
| Measure Quantitated Myocardial Perfusion Reserve After a 1 Minute Delay in Lexiscan (Regadenoson) | 1 minute | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| 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. | 20 |
| 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. | 20 |
| 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. | 20 |
| Total | 80 |
Baseline characteristics
| Characteristic | 10 Second Delay | 2 Minute Delay | 4 Minute Delay | 1 Minute Delay | Total |
|---|---|---|---|---|---|
| Age, Continuous | 50.5 Years STANDARD_DEVIATION 13.8 | 51.3 Years STANDARD_DEVIATION 10.4 | 53.1 Years STANDARD_DEVIATION 9.6 | 50.6 Years STANDARD_DEVIATION 9.9 | 51.9 Years STANDARD_DEVIATION 11 |
| Region of Enrollment United States | 20 participants | 20 participants | 20 participants | 20 participants | 80 participants |
| Sex: Female, Male Female | 14 Participants | 6 Participants | 10 Participants | 15 Participants | 45 Participants |
| Sex: Female, Male Male | 6 Participants | 14 Participants | 10 Participants | 5 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 | 0 / 19 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 19 | 1 / 20 |
Outcome results
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.
Time frame: 10 seconds
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| 4 Minute Delay | Measure Quantitated Myocardial Perfusion Reserve After a 10 Second Delay in Lexiscan (Regadenoson) | 2.34 Ratio | Standard Deviation 0.38 |
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.
Time frame: 1 minute
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 4 Minute Delay | Measure Quantitated Myocardial Perfusion Reserve After a 1 Minute Delay in Lexiscan (Regadenoson) | 2.76 Ratio | Standard Deviation 0.56 |
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.
Time frame: 2 mintues
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 4 Minute Delay | Measure Quantitated Myocardial Perfusion Reserve After a 2 Minute Delay in Lexiscan (Regadenoson) | 2.93 Ratio | Standard Deviation 0.7 |
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.
Time frame: 4 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 4 Minute Delay | Measure Quantitated Myocardial Perfusion Reserve After a 4 Minute Delay in Lexiscan (Regadenoson) | 2.57 Ratio | Standard Deviation 0.71 |