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

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ClinicalTrials.gov Identifier: NCT01919450
Recruitment Status : Completed
First Posted : August 9, 2013
Results First Posted : March 27, 2017
Last Update Posted : August 16, 2018
Sponsor:
Information provided by (Responsible Party):
Timothy M. Bateman, MD, Cardiovascular Imaging Technologies

Study Description
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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.

Condition or disease Intervention/treatment Phase
Myocardial Blood Flow Reserve Drug: Regadenoson Radiation: Rubidium-82 Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Characterization of Myocardial Blood Flow Measurements Using Lexiscan®™ (Regadenoson) (Lexiscan®™) Rubidium-82 Myocardial Perfusion PET: A Temporal-Dependency Investigation
Study Start Date : July 2013
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 10 Second Delay
A 10 second delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.
 Drug: Regadenoson
Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.
Other Name: Lexiscan

Radiation: Rubidium-82
Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.
Other Name: Cardio-Gen82
Active Comparator: 2 Minute Delay
A 2 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.
 Drug: Regadenoson
Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.
Other Name: Lexiscan

Radiation: Rubidium-82
Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.
Other Name: Cardio-Gen82
Active Comparator: 4 Minute Delay
A 4 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.
 Drug: Regadenoson
Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.
Other Name: Lexiscan

Radiation: Rubidium-82
Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.
Other Name: Cardio-Gen82
Active Comparator: 1 Minute Delay
A 1 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.
 Drug: Regadenoson
Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.
Other Name: Lexiscan

Radiation: Rubidium-82
Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.
Other Name: Cardio-Gen82


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01919450


Locations
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United States, Missouri
Saint Luke's Hospital Imaging Center
Kansas City, Missouri, United States, 64111
Sponsors and Collaborators
Timothy M. Bateman, MD
Investigators
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Principal Investigator: Timothy M Bateman, MD Cardiovascular Imaging Technologies
More Information
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Responsible Party: Timothy M. Bateman, MD, Medical Director, Cardiovascular Imaging Technologies
ClinicalTrials.gov Identifier: NCT01919450    
Other Study ID Numbers: 13-058
First Posted: August 9, 2013    Key Record Dates
Results First Posted: March 27, 2017
Last Update Posted: August 16, 2018
Last Verified: July 2018
Keywords provided by Timothy M. Bateman, MD, Cardiovascular Imaging Technologies:
PET
Lexiscan
Regadenoson
Rubidium
 Blood Flow Reserve
Myocardial Perfusion
Quantitated Myocardial Perfusion
Additional relevant MeSH terms:
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Regadenoson
Adenosine A2 Receptor Agonists
Purinergic P1 Receptor Agonists
Purinergic Agonists
 Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs