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

Cardiovascular Imaging Technologies

Status and phase: Unknown; Phase 4

Conditions: Coronary Artery Disease

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00808314

08-271

Details and patient eligibility

About

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.

Enrollment: 32 estimated patients

Sex: All

Ages: 35 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

LL for CAD

Active Comparator group

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.

Treatment:

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

Drug: Rest/Dipyridamole Stress Rb-82 Myocardial Perfusion PET/CT

CAD

Active Comparator group

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.

Treatment:

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