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

This study is currently recruiting participants.
Verified November 2013 by Aspire Foundation
Sponsor:
Collaborators:
BlueCross BlueShield of Kansas City
Cardiovascular Imaging Technologies
Saint Luke's Cardiovascular Consultants
Mid America Heart Institute
Information provided by (Responsible Party):
Staci Courter, MA, Aspire Foundation
ClinicalTrials.gov Identifier:
NCT00976053
First received: September 11, 2009
Last updated: November 20, 2013
Last verified: November 2013
  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 4

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:


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: September 2014
Primary Completion Date: September 2013 (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:

  • 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
  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: Staci Courter, MA, Clinical Research Coordinator, Aspire Foundation
ClinicalTrials.gov Identifier: NCT00976053     History of Changes
Other Study ID Numbers: 09-307
Study First Received: September 11, 2009
Last Updated: November 20, 2013
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 April 16, 2014