Characterization of Myocardial Blood Flow Measurements Using Lexiscan®™ (Regadenoson) (Lexiscan®™) Rubidium-82 Myocardial Perfusion PET: A Temporal-Dependency Investigation

Study Overview
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Brief Summary
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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.

Official Title
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Characterization of Myocardial Blood Flow Measurements Using Lexiscan®™ (Regadenoson) (Lexiscan®™) Rubidium-82 Myocardial Perfusion PET: A Temporal-Dependency Investigation

Conditions
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Myocardial Blood Flow Reserve

Intervention / Treatment
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* Drug: Regadenoson
* Radiation: Rubidium-82


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 10 Second Delay<br>A 10 second delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging. | Drug: Regadenoson<br>* Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.<br>* Other names: Lexiscan;Radiation: Rubidium-82<br>* Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.<br>* Other names: Cardio-Gen82;|
| Active Comparator: 2 Minute Delay<br>A 2 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging. | Drug: Regadenoson<br>* Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.<br>* Other names: Lexiscan;Radiation: Rubidium-82<br>* Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.<br>* Other names: Cardio-Gen82;|
| Active Comparator: 4 Minute Delay<br>A 4 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging. | Drug: Regadenoson<br>* Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.<br>* Other names: Lexiscan;Radiation: Rubidium-82<br>* Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.<br>* Other names: Cardio-Gen82;|
| Active Comparator: 1 Minute Delay<br>A 1 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging. | Drug: Regadenoson<br>* Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.<br>* Other names: Lexiscan;Radiation: Rubidium-82<br>* Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.<br>* Other names: Cardio-Gen82;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PET, Lexiscan, Regadenoson, Rubidium, Blood Flow Reserve, Myocardial Perfusion, Quantitated Myocardial Perfusion