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

Phase 4

Completed

• Conditions: Coronary Artery Disease
• Interventions: Procedure: Myocardial perfusion imaging

• Registration Number: NCT00976053
• Lead Sponsor: Aspire Foundation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-09-11
• Study First Submitted QC: 2009-09-11
• Study First Posted: 2009-09-14
• Primary Completion: 2013-09
• Status Verified: 2014-10
• Study Completion: 2014-10
• Last Update Submitted: 2014-10-30
• Last Update Posted: 2014-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SPECT myocardial perfusion imaging	Myocardial perfusion imaging	-
PET myocardial perfusion imaging	Myocardial perfusion imaging	-

Primary Outcome Measures

Name	Time	Method
Diagnostic failure of SPECT vs PET	60 days

Secondary Outcome Measures

Name	Time	Method
Each of individual components of clinical failure	12 months
Relative direct and downstream costs	3 months, 6 months, 12 months
Composite of diagnostic or clinical failure	12 months
Relative effect on quality of life	3 months, 6 months

Trial Locations

Locations (1)

Saint Luke's Cardiovascular Consultants; 🇺🇸 Kansas City, Missouri, United States