Lexiscan(TM) Rb-82 Myocardial Perfusion PET: A Comparison With Dipyridamole Stress - Full Text View

Sponsors and Collaborators:	Cardiovascular Imaging Technologies Astellas Pharma US, Inc.
Information provided by:	Cardiovascular Imaging Technologies
ClinicalTrials.gov Identifier:	NCT00808314

Purpose

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.

Condition	Intervention	Phase
Coronary Artery Disease	Drug: Rest/Dipyridamole Stress Rb-82 Myocardial Perfusion PET/CT Drug: Rest/Lexiscan(TM) Stress Rb-82 Myocardial Perfusion PET	Phase IV

MedlinePlus related topics: CT Scans Coronary Artery Disease

Drug Information available for: Dipyridamole CVT 3146

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Parallel Assignment
Official Title:	Lexiscan(TM) Rb-82 Myocardial Perfusion Positron Emission Computed Tomography: A Comparison With Dipyridamole

Further study details as provided by Cardiovascular Imaging Technologies:

Primary Outcome Measures:

Quantitative analysis of local and regional myocardial perfusion between Lexiscan(TM) and dipyridamole rest/stress Rb82 PET [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	32
Study Start Date:	December 2008
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
LL for CAD: 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.	Drug: 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. Drug: 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.
CAD: 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.	Drug: 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.

Arms

Assigned Interventions

LL for CAD: 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.

Drug: 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.

Drug: 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.

CAD: 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.

Drug: 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.

Eligibility

Ages Eligible for Study:	35 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00808314

Locations

United States, Missouri
Cardiovascular Consultants
Kansas City, Missouri, United States, 64111

Sponsors and Collaborators

Cardiovascular Imaging Technologies

Astellas Pharma US, Inc.

Investigators

Principal Investigator:

Timothy M Bateman, MD

Cardiovascular Imaging Technologies

More Information

Responsible Party:	Cardiodiovascular Imaging Technologies ( Timothy M. Bateman, MD )
Study ID Numbers:	08-271
Study First Received:	December 12, 2008
Last Updated:	December 12, 2008
ClinicalTrials.gov Identifier:	NCT00808314
Health Authority:	United States: Institutional Review Board

Keywords provided by Cardiovascular Imaging Technologies:

Lexiscan(TM)
Dipyridamole
Myocardial Perfusion
Positron Emission Computed Tomography

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Stress
Arteriosclerosis
Ischemia
Dipyridamole
Coronary Artery Disease

Additional relevant MeSH terms:

Vasodilator Agents
Phosphodiesterase Inhibitors
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Hematologic Agents

Platelet Aggregation Inhibitors
Enzyme Inhibitors
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009