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

July 19, 2018 updated by: Timothy M. Bateman, MD
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Hospital Imaging Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 minutes
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.
2 mintues
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.
10 seconds
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.
1 minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Timothy M. Bateman, MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

July 25, 2013

First Submitted That Met QC Criteria

August 8, 2013

First Posted (Estimate)

August 9, 2013

Study Record Updates

Last Update Posted (Actual)

August 16, 2018

Last Update Submitted That Met QC Criteria

July 19, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-058

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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