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

This study is currently recruiting participants.

Verified April 2011 by Aspire Foundation

First Received on September 11, 2009. Last Updated on April 21, 2011 History of Changes

Sponsor:	Aspire Foundation
Collaborators:	BlueCross BlueShield of Kansas City Cardiovascular Imaging Technologies Saint Luke's Cardiovascular Consultants Mid America Heart Institute
Information provided by:	Aspire Foundation
ClinicalTrials.gov Identifier:	NCT00976053

Purpose

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.

Condition	Intervention	Phase
Symptomatic Coronary Artery Disease	Procedure: Myocardial perfusion imaging	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic
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)

Resource links provided by NLM:

MedlinePlus related topics: CT Scans Coronary Artery Disease

U.S. FDA Resources

Further study details as provided by Aspire Foundation:

Primary Outcome Measures:

Diagnostic failure of SPECT vs PET [ Time Frame: 60 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Composite of diagnostic or clinical failure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Each of individual components of clinical failure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Relative effect on quality of life [ Time Frame: 3 months, 6 months ] [ Designated as safety issue: No ]
Relative direct and downstream costs [ Time Frame: 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	330
Study Start Date:	June 2009
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: SPECT myocardial perfusion imaging	Procedure: Myocardial perfusion imaging Randomization assignment to one of SPECT or PET myocardial perfusion imaging
Active Comparator: PET myocardial perfusion imaging	Procedure: Myocardial perfusion imaging Randomization assignment to one of SPECT or PET myocardial perfusion imaging

Eligibility

Ages Eligible for Study:	30 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Prior Q-wave myocardial infarction
Creatinine above 2.5 mg%
Prior coronary artery bypass surgery
PCI within prior 6 months
Pregnant females
Cardiomyopathy (LVEF below 40%)
Significant valvular heart disease
Body mass index greater than 38

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00976053

Contacts

Contact: Timothy M Bateman, M.D.	816-751-8542	tbateman@cc-pc.com
Contact: Staci A Courter, M.A.	816-531-2842 ext 107	scourter@cvit.com

Locations

United States, Missouri
Saint Luke's Cardiovascular Consultants	Recruiting
Kansas City, Missouri, United States, 64111
Contact: Timothy M Bateman, M.D. 816-751-8542 tbateman@cc-pc.com
Contact: Staci A Courter, M.A. 816-531-2842 ext 107 scourter@cvit.com
Principal Investigator: Timothy M Bateman, M.D.
Sub-Investigator: Iain A McGhie, M.D.

Sponsors and Collaborators

Aspire Foundation

BlueCross BlueShield of Kansas City

Cardiovascular Imaging Technologies

Saint Luke's Cardiovascular Consultants

Mid America Heart Institute

Investigators

Principal Investigator:

Timothy M Bateman, M.D.

Aspire Foundation

More Information

No publications provided

Responsible Party:	Timothy M. Bateman, MD, ASPIRE Foundation
ClinicalTrials.gov Identifier:	NCT00976053 History of Changes
Other Study ID Numbers:	09-307
Study First Received:	September 11, 2009
Last Updated:	April 21, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Aspire Foundation:

Coronary artery disease
Myocardial perfusion imaging
Single photon emission computed tomography
Positron emission tomography

Additional relevant MeSH terms:

Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases

Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on February 09, 2012