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Completed

NCT Number: NCT01919450

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

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.

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Key information

Conditions

Myocardial Blood Flow Reserve

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Saint Luke's Hospital Imaging Center

Kansas City, Missouri, 64111, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Regadenoson

Drug

Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.

Other names: Lexiscan

Rubidium-82

Radiation

Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.

Other names: Cardio-Gen82

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Timothy M. Bateman, MD

Industry

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Aug 9, 2013
Registry last updated
Aug 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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