Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Cardiovascular Imaging Technologies.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
Timothy M. Bateman, MD, Cardiovascular Imaging Technologies
ClinicalTrials.gov Identifier:
NCT00808314
First received: December 12, 2008
Last updated: August 1, 2012
Last verified: August 2012

December 12, 2008
August 1, 2012
December 2008
December 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00808314 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Lexiscan(TM) Rb-82 Myocardial Perfusion PET: A Comparison With Dipyridamole Stress
Lexiscan(TM) Rb-82 Myocardial Perfusion Positron Emission Computed Tomography: A Comparison With Dipyridamole

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Coronary Artery Disease
  • 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: 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.
    Interventions:
    • Drug: Rest/Dipyridamole Stress Rb-82 Myocardial Perfusion PET/CT
    • Drug: Rest/Lexiscan(TM) Stress Rb-82 Myocardial Perfusion PET
  • 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.
    Intervention: Drug: Rest/Lexiscan(TM) Stress Rb-82 Myocardial Perfusion PET
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
32
September 2012
December 2010   (final data collection date for primary outcome measure)

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
Both
35 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00808314
08-271
No
Timothy M. Bateman, MD, Cardiovascular Imaging Technologies
Cardiovascular Imaging Technologies
Astellas Pharma US, Inc.
Principal Investigator: Timothy M Bateman, MD Cardiovascular Imaging Technologies
Cardiovascular Imaging Technologies
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP