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

This study has been completed.
Sponsor:
Collaborators:
Blue Cross Blue Shield
Cardiovascular Imaging Technologies
Saint Luke's Cardiovascular Consultants
Mid America Heart Institute
Information provided by (Responsible Party):
Timothy M. Bateman, Aspire Foundation
ClinicalTrials.gov Identifier:
NCT00976053
First received: September 11, 2009
Last updated: October 30, 2014
Last verified: October 2014
  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
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 ]

Enrollment: 330
Study Start Date: June 2009
Study Completion Date: October 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Missouri
Saint Luke's Cardiovascular Consultants
Kansas City, Missouri, United States, 64111
Sponsors and Collaborators
Aspire Foundation
Blue Cross Blue Shield
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, Prinicpal Investigator/Medical Director, Aspire Foundation
ClinicalTrials.gov Identifier: NCT00976053     History of Changes
Other Study ID Numbers: 09-307
Study First Received: September 11, 2009
Last Updated: October 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Aspire Foundation:
Myocardial perfusion imaging
Single photon emission computed tomography
Positron emission tomography

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014