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

Primary Purpose

Coronary Artery Disease

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Rest/Dipyridamole Stress Rb-82 Myocardial Perfusion PET/CT
Rest/Lexiscan(TM) Stress Rb-82 Myocardial Perfusion PET
Sponsored by
Cardiovascular Imaging Technologies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Lexiscan(TM), Dipyridamole, Myocardial Perfusion, Positron Emission Computed Tomography

Eligibility Criteria

35 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Saint Luke's Cardiovascular Consultants

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

LL for CAD

CAD

Arm Description

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.

Subjects with existing mild-moderate ishemia demonstrated by a recent (< 1 month) rest/stress dipyridamole PET will undergo a rest/stress Lexiscan(TM) PET.

Outcomes

Primary Outcome Measures

Quantitative analysis of local and regional myocardial perfusion between Lexiscan(TM) and dipyridamole rest/stress Rb82 PET

Secondary Outcome Measures

Full Information

First Posted
December 12, 2008
Last Updated
August 1, 2012
Sponsor
Cardiovascular Imaging Technologies
Collaborators
Astellas Pharma US, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00808314
Brief Title
Lexiscan(TM) Rb-82 Myocardial Perfusion PET: A Comparison With Dipyridamole Stress
Official Title
Lexiscan(TM) Rb-82 Myocardial Perfusion Positron Emission Computed Tomography: A Comparison With Dipyridamole
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
December 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
September 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cardiovascular Imaging Technologies
Collaborators
Astellas Pharma US, Inc.

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Lexiscan(TM), Dipyridamole, Myocardial Perfusion, Positron Emission Computed Tomography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LL for CAD
Arm Type
Active Comparator
Arm Description
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.
Arm Title
CAD
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Rest/Dipyridamole Stress Rb-82 Myocardial Perfusion PET/CT
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Rest/Lexiscan(TM) Stress Rb-82 Myocardial Perfusion PET
Intervention Description
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 Outcome Measure Information:
Title
Quantitative analysis of local and regional myocardial perfusion between Lexiscan(TM) and dipyridamole rest/stress Rb82 PET
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy M Bateman, MD
Organizational Affiliation
Cardiovascular Imaging Technologies
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Luke's Cardiovascular Consultants
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States

12. IPD Sharing Statement

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

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