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

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ClinicalTrials.gov Identifier: NCT00808314
Recruitment Status : Unknown
Verified August 2012 by Timothy M. Bateman, MD, Cardiovascular Imaging Technologies.
Recruitment status was:  Active, not recruiting
First Posted : December 15, 2008
Last Update Posted : August 2, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment 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 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Lexiscan(TM) Rb-82 Myocardial Perfusion Positron Emission Computed Tomography: A Comparison With Dipyridamole
Study Start Date : December 2008
Primary Completion Date : December 2010
Estimated Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: LL for CAD
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.
Active Comparator: CAD
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.


Outcome Measures

Primary Outcome Measures :
  1. Quantitative analysis of local and regional myocardial perfusion between Lexiscan(TM) and dipyridamole rest/stress Rb82 PET [ Time Frame: 12 months ]

Eligibility Criteria

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Ages Eligible for Study:   35 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00808314


Locations
United States, Missouri
Saint Luke's 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: Timothy M. Bateman, MD, Principal Investigator, Cardiovascular Imaging Technologies
ClinicalTrials.gov Identifier: NCT00808314     History of Changes
Other Study ID Numbers: 08-271
First Posted: December 15, 2008    Key Record Dates
Last Update Posted: August 2, 2012
Last Verified: August 2012

Keywords provided by Timothy M. Bateman, MD, Cardiovascular Imaging Technologies:
Lexiscan(TM)
Dipyridamole
Myocardial Perfusion
Positron Emission Computed Tomography

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Dipyridamole
Regadenoson
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Vasodilator Agents
Adenosine A2 Receptor Agonists
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs