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

NCT01919450 | Completed Phase 4 Results

• 1 other identifier: 13-058
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Blood Flow Reserve

Keywords

PET; Lexiscan; Regadenoson; Rubidium; Blood Flow Reserve; Myocardial Perfusion; Quantitated Myocardial Perfusion

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  1 minute

Study Arms (4)

10 Second Delay

ACTIVE COMPARATOR

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

Drug: Regadenoson; Radiation: Rubidium-82

2 Minute Delay

ACTIVE COMPARATOR

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

Drug: Regadenoson; Radiation: Rubidium-82

4 Minute Delay

ACTIVE COMPARATOR

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

Drug: Regadenoson; Radiation: Rubidium-82

1 Minute Delay

ACTIVE COMPARATOR

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

Drug: Regadenoson; Radiation: Rubidium-82

Interventions

Regadenoson DRUG

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

Also known as: Lexiscan

1 Minute Delay; 10 Second Delay; 2 Minute Delay; 4 Minute Delay

Rubidium-82 RADIATION

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

Also known as: Cardio-Gen82

1 Minute Delay; 10 Second Delay; 2 Minute Delay; 4 Minute Delay

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Timothy M. Bateman, MD: lead

Study Sites (1)

Saint Luke's Hospital Imaging Center

Kansas City, Missouri, 64111, United States

Location

MeSH Terms

Interventions

regadenoson; Rubidium-82

Results Point of Contact

• Title: Timothy M. Bateman, MD
• Organization: Cardiovascular Imaging Technologies, LLC

tbateman@cvit.com

816-531-2842

Study Officials

• Timothy M Bateman, MD

  Cardiovascular Imaging Technologies

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: July 25, 2013
• First Posted: August 9, 2013
• Study Start: July 1, 2013
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: August 16, 2018
• Results First Posted: March 27, 2017

Record last verified: 2018-07

Locations

US (1)