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

NCT00808314 | Unknown Phase 4

• 1 other identifier: 08-271
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

Lexiscan(TM); Dipyridamole; Myocardial Perfusion; Positron Emission Computed Tomography

Outcome Measures

Primary Outcomes (1)

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

  12 months

Study Arms (2)

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; Drug: Rest/Lexiscan(TM) Stress Rb-82 Myocardial Perfusion PET

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

Interventions

Rest/Dipyridamole Stress Rb-82 Myocardial Perfusion PET/CT DRUG

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.

LL for CAD

Rest/Lexiscan(TM) Stress Rb-82 Myocardial Perfusion PET DRUG

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; LL for CAD

Eligibility Criteria

• Age: 35 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI \<35
• No intervention or change in management between dipyridamole and Lexiscan(TM) PET

You may not qualify if:

• BMI \>35
• An intervention or change in management between dipyridamole and Lexiscan(TM) PET

Sponsors & Collaborators

• Cardiovascular Imaging Technologies: lead
• Astellas Pharma US, Inc.: collaborator

Study Sites (1)

Saint Luke's Cardiovascular Consultants

Kansas City, Missouri, 64111, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Timothy M Bateman, MD

  Cardiovascular Imaging Technologies

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 12, 2008
• First Posted: December 15, 2008
• Study Start: December 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: September 1, 2012
• Last Updated: August 2, 2012

Record last verified: 2012-08

Locations

US (1)