Overview

This trial is active, not recruiting.

Condition coronary artery disease
Treatments rest/dipyridamole stress rb-82 myocardial perfusion pet/ct, rest/lexiscan(tm) stress rb-82 myocardial perfusion pet
Phase phase 4
Sponsor Cardiovascular Imaging Technologies
Collaborator Astellas Pharma US, Inc.
Start date December 2008
End date December 2010
Trial size 32 participants
Trial identifier NCT00808314, 08-271

Summary

Lexiscan(TM) has ideal properties for Rb-82 PET imaging and the stress response it invokes may offer multiple advantages for the diagnosis of coronary disease and functional abnormalities. The goal of this investigation is to establish quantitative equivalence of Lexiscan(TM) rest/stress Rb-82 PET images to dipyridamole rest/stress images.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose diagnostic
Arm
(Active Comparator)
Subjects with <5% pre-test low likelihood for CAD based on Diamond and Forrester criteria will be recruited to undergo both rest/stress dipyridamole PET followed by a rest/stress Lexiscan(TM) PET with 30 days.
rest/dipyridamole stress rb-82 myocardial perfusion pet/ct
A CT scan will be acquired for attenuation correction of the rest image (9 mA, 120 kVp, 4.24 secs) during end-expiration breath-holding. This will be followed by infusion of approximately 60 mCi of Rb-82, 60 to 100 seconds after which resting images will be acquired with ECG-gating. Following rest imaging, 0.56 mg/kg of dipyridamole will be infused over 4 minutes. Three minutes after the completion of the infusion, approximately 60 mCi of Rb-82 will be infused. Peak stress images will be acquired with ECG-gating, starting 90 seconds after the the beginning of the infusion of Rb-82 and continuing for 5 minutes. A CT scan will be acquired for attenuation correction of the stress image (9 mA, 120 kVp, 4.24 secs) during end-expiration breath-holding.
rest/lexiscan(tm) stress rb-82 myocardial perfusion pet
A CT scan will be acquired for attenuation correction of the rest image (9 mA, 120 kVp, 4.24 secs) during end-expiration breath-holding. This will be followed by infusion of approximately 60 mCi of Rb-82, 60 to 100 seconds after which resting images will be acquired with ECG-gating. Following rest imaging, 400 umg of Lexiscan(TM) will be injected, and then approximately 60 mCi of Rb-82 waill be infused. Peak stress images will be acquired in list mode with ECG-gating, starting 90 seconds after the the beginning of the infusion of Rb-82 and continuing for 5 minutes. A CT scan willbe acquired for attenuation correction of the stress image (9 mA, 120 kVp, 4.24 secs) during end-expiration breath-holding.
(Active Comparator)
Subjects with existing mild-moderate ishemia demonstrated by a recent (< 1 month) rest/stress dipyridamole PET will undergo a rest/stress Lexiscan(TM) PET.
rest/lexiscan(tm) stress rb-82 myocardial perfusion pet
A CT scan will be acquired for attenuation correction of the rest image (9 mA, 120 kVp, 4.24 secs) during end-expiration breath-holding. This will be followed by infusion of approximately 60 mCi of Rb-82, 60 to 100 seconds after which resting images will be acquired with ECG-gating. Following rest imaging, 400 umg of Lexiscan(TM) will be injected, and then approximately 60 mCi of Rb-82 waill be infused. Peak stress images will be acquired in list mode with ECG-gating, starting 90 seconds after the the beginning of the infusion of Rb-82 and continuing for 5 minutes. A CT scan willbe acquired for attenuation correction of the stress image (9 mA, 120 kVp, 4.24 secs) during end-expiration breath-holding.

Primary Outcomes

Measure
Quantitative analysis of local and regional myocardial perfusion between Lexiscan(TM) and dipyridamole rest/stress Rb82 PET
time frame: 12 months

Eligibility Criteria

Male or female participants from 35 years up to 90 years old.

Inclusion Criteria: - BMI <35 - No intervention or change in management between dipyridamole and Lexiscan(TM) PET Exclusion Criteria: - BMI >35 - An intervention or change in management between dipyridamole and Lexiscan(TM) PET

Additional Information

Official title Lexiscan(TM) Rb-82 Myocardial Perfusion Positron Emission Computed Tomography: A Comparison With Dipyridamole
Principal investigator Timothy M Bateman, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2012.
Information provided to ClinicalTrials.gov by Cardiovascular Imaging Technologies.