Characterization of Myocardial Blood Flow Measurements Using Lexiscan®™ (Regadenoson) (Lexiscan®™) Rubidium-82 Myocardial Perfusion PET: A Temporal-Dependency Investigation
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Timothy M. Bateman, MD
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Measure Quantitated Myocardial Perfusion Reserve After a 4 Minute Delay in Lexiscan (Regadenoson)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
10 Second Delay
A 10 second delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.
Intervention: Regadenoson (Drug)
10 Second Delay
A 10 second delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.
Intervention: Rubidium-82 (Radiation)
2 Minute Delay
A 2 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.
Intervention: Regadenoson (Drug)
2 Minute Delay
A 2 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.
Intervention: Rubidium-82 (Radiation)
4 Minute Delay
A 4 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.
Intervention: Regadenoson (Drug)
4 Minute Delay
A 4 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.
Intervention: Rubidium-82 (Radiation)
1 Minute Delay
A 1 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.
Intervention: Regadenoson (Drug)
1 Minute Delay
A 1 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.
Intervention: Rubidium-82 (Radiation)
Outcomes
Primary Outcomes
Measure Quantitated Myocardial Perfusion Reserve After a 4 Minute Delay in Lexiscan (Regadenoson)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Timothy M. Bateman, MD
Medical Director
Cardiovascular Imaging Technologies