Effectiveness Study of Single Photon Emission Computed Tomography (SPECT) Versus Positron Emission Tomography (PET) Myocardial Perfusion Imaging

Aspire Foundation

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Disease

Treatments: Procedure: Myocardial perfusion imaging

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00976053

09-307

Details and patient eligibility

About

The purpose of this study is to compare pharmacologic stress myocardial perfusion PET with pharmacologic stress myocardial perfusion SPECT in a near-simultaneous, head-to-head comparison in the same patient. The investigators hypothesize that pharmacologic stress myocardial perfusion PET will prove superior to pharmacologic stress myocardial perfusion SPECT as a first-line diagnostic test for higher-risk patients with known coronary artery disease (CAD) who present with symptoms consistent with possible worsening of their CAD.

Enrollment: 330 patients

Sex: All

Ages: 30 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• History of coronary artery disease
• New or worsening symptoms
• Out-patients and in-hospital patients

Exclusion criteria

• Creatinine above 2.5 mg%
• PCI within prior 6 months
• Pregnant females
• Cardiomyopathy (LVEF below 40%)
• Significant valvular heart disease
• Body mass index greater than 38

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

330 participants in 2 patient groups

SPECT myocardial perfusion imaging

Active Comparator group

Treatment:

Procedure: Myocardial perfusion imaging

PET myocardial perfusion imaging

Active Comparator group

Treatment:

Procedure: Myocardial perfusion imaging