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

Coronary Artery Disease Clinical Trial

Official title:

Clinical Effectiveness of Pharmacologic Stress Radionuclide Myocardial Perfusion Imaging as a Guide to Management of Patients With Known CAD: Comparison of Single-Photon Emission Computed Tomography (SPECT) and Positron Emission Tomography (PET)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00976053
• Other study ID #: 09-307
• Status: Completed
• Phase: Phase 4
• First received: September 11, 2009
• Last updated: October 30, 2014
• Start date: June 2009
• Est. completion date: October 2014

Study information

• Verified date: October 2014
• Source: Aspire Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: October 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• Myocardial perfusion imaging
Randomization assignment to one of SPECT or PET myocardial perfusion imaging

Locations

Country	Name	City	State
United States	Saint Luke's Cardiovascular Consultants	Kansas City	Missouri

Sponsors (5)

Lead Sponsor	Collaborator
Aspire Foundation	Blue Cross Blue Shield, Cardiovascular Imaging Technologies, Mid America Heart Institute, Saint Luke's Cardiovascular Consultants

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic failure of SPECT vs PET		60 days	No
Secondary	Composite of diagnostic or clinical failure		12 months	No
Secondary	Each of individual components of clinical failure		12 months	No
Secondary	Relative effect on quality of life		3 months, 6 months	No
Secondary	Relative direct and downstream costs		3 months, 6 months, 12 months	No