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

This study is ongoing, but not recruiting participants.

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

History of Changes

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 4

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

Resource links provided by NLM:

MedlinePlus related topics: CT Scans Coronary Artery Disease

Drug Information available for: Dipyridamole Regadenoson

U.S. FDA Resources

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 Study Completion Date:	September 2012
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

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
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

No publications provided

Responsible Party:	Timothy M. Bateman, MD, Principal Investigator, Cardiovascular Imaging Technologies
ClinicalTrials.gov Identifier:	NCT00808314 History of Changes
Other Study ID Numbers:	08-271
Study First Received:	December 12, 2008
Last Updated:	August 1, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by 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

Pharmacologic Actions
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Vasodilator Agents
Cardiovascular Agents
Adenosine A2 Receptor Antagonists
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013

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