NCT01919450 - Characterization of Myocardial Blood Flow Measurements Using Lexiscan®™ (Regadenoson) (Lexiscan®™) Rubidium-82 Myocardial Perfusion PET: A Temporal-Dependency Investigation | Crick

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

80

Conditions

Myocardial Blood Flow Reserve

Interventions

RegadenosonDRUG

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

Rubidium-82RADIATION

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

Eligibility

Sex: ALLMin age: 40 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Saint Luke's Hospital Imaging Center

Kansas City, Missouri, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 1 minute