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

Phase 4

Completed

• Conditions: Myocardial Blood Flow Reserve
• Interventions: Drug: Regadenoson; Radiation: Rubidium-82

• Registration Number: NCT01919450
• Lead Sponsor: Timothy M. Bateman, MD

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-25
• Study First Submitted QC: 2013-08-08
• Study First Posted: 2013-08-09
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Results First Submitted: 2016-10-25
• Results First Submitted QC: 2017-02-07
• Results First Posted: 2017-03-27
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-19
• Last Update Posted: 2018-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
10 Second Delay	Regadenoson	A 10 second delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.
10 Second Delay	Rubidium-82	A 10 second delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.
2 Minute Delay	Rubidium-82	A 2 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.
4 Minute Delay	Regadenoson	A 4 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.
4 Minute Delay	Rubidium-82	A 4 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.
1 Minute Delay	Regadenoson	A 1 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.
1 Minute Delay	Rubidium-82	A 1 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.
2 Minute Delay	Regadenoson	A 2 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.

Primary Outcome Measures

Name	Time	Method
Measure Quantitated Myocardial Perfusion Reserve After a 4 Minute Delay in Lexiscan (Regadenoson)	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.
Measure Quantitated Myocardial Perfusion Reserve After a 2 Minute Delay in Lexiscan (Regadenoson)	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.
Measure Quantitated Myocardial Perfusion Reserve After a 10 Second Delay in Lexiscan (Regadenoson)	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.
Measure Quantitated Myocardial Perfusion Reserve After a 1 Minute Delay in Lexiscan (Regadenoson)	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.

Trial Locations

Locations (1)

Saint Luke's Hospital Imaging Center; 🇺🇸 Kansas City, Missouri, United States