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

NCT ID: NCT01919450

Last Updated: 2018-08-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2016-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Myocardial Blood Flow Reserve

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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10 Second Delay

A 10 second delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.

Group Type ACTIVE_COMPARATOR

Regadenoson

Intervention Type DRUG

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

Rubidium-82

Intervention Type RADIATION

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

2 Minute Delay

A 2 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.

Group Type ACTIVE_COMPARATOR

Regadenoson

Intervention Type DRUG

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

Rubidium-82

Intervention Type RADIATION

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

4 Minute Delay

A 4 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.

Group Type ACTIVE_COMPARATOR

Regadenoson

Intervention Type DRUG

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

Rubidium-82

Intervention Type RADIATION

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

1 Minute Delay

A 1 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.

Group Type ACTIVE_COMPARATOR

Regadenoson

Intervention Type DRUG

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

Rubidium-82

Intervention Type RADIATION

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

Interventions

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Regadenoson

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

Intervention Type DRUG

Rubidium-82

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

Intervention Type RADIATION

Other Intervention Names

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Lexiscan Cardio-Gen82

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Timothy M. Bateman, MD

INDUSTRY

Sponsor Role lead

Responsible Party

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Timothy M. Bateman, MD

Medical Director

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Timothy M Bateman, MD

Role: PRINCIPAL_INVESTIGATOR

Cardiovascular Imaging Technologies

Locations

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Saint Luke's Hospital Imaging Center

Kansas City, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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13-058

Identifier Type: -

Identifier Source: org_study_id

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