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Efficiency and Outcomes of Stress-Only Anger and D-SPECT Stress-Only SPECT MPI

This study has been completed.
Sponsor:
Collaborators:
Spectrum Dynamics
Cardiovascular Imaging Technologies, LLC
Saint Luke's Cardiovascular Consultants
Mid America Heart Institute
Information provided by:
Aspire Foundation
ClinicalTrials.gov Identifier:
NCT01373944
First received: June 14, 2011
Last updated: March 23, 2012
Last verified: March 2012
History of Changes
  Purpose

The purpose of this study is to compare clinical efficiency and patient outcomes using ultra low-dose stress only Tc-99m and solid-state SPECT versus traditional Anger SPECT.


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Rapid-Acquisition Low-Dosimetry Tc-99m Stress-Only Myocardial Perfusion SPECT on the Spectrum Dynamics System: Comparison of Efficiency and Outcomes With Stress-Only Anger SPECT

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Aspire Foundation:

Primary Outcome Measures:
  • Diagnostic Failure [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Diagnostic failure is defined by a composite of need for additional downstream testing (anger SPECT, MPI PET, stress echocardiography or coronary CT angiography) within 30 days or a coronary angiogram with no stenoses greater than or equal to 50% severity using quantitative coronary angiography.


Secondary Outcome Measures:
  • Necessity to proceed to a rest image [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    The first of 4 secondary end-points is the need to proceed to a rest image.

  • Necessity for additional downstream testing [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    The second of four secondary endpoints the need for additional downstream testing within 30 days to address the same clincial reason for the innitial referral for stress-onoly imaging, in the absence of any changes in clincial status between tests.

  • Coronary Angiography [ Time Frame: 60 to 90 days ] [ Designated as safety issue: No ]
    The third of four secondary end-points is the occurrence of coronary angiography with no stenoses greater than or equal to 50% severity using quantitative coronary angiography.

  • Determine optimal performance of the Spectrum Dynamics camera system for stress only imaging [ Time Frame: 60 to 90 days ] [ Designated as safety issue: No ]
    The fourth of four secondary endpoints is to determine optimal performance of the Spectrum Dynamics camera system for stress only imaging: upright imaging alone, supine imaging alone, or both in terms of primary and secondary endpoints


Enrollment: 500
Study Start Date: May 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Stress Only SPECT MPI with Anger Camera
Patients undergoing clinically-indicated stress-only sestamibi studies who are imaged on the traditional Anger camera
Stress Only SPECT MPI with SD Camera
Patients undergoing clinically-indicated stress-only sestamibi studies who are imaged on the Spectrum Dynamics camera system.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Consecutive patients referred for clinically-indicated myocardial perfusion SPECT

Criteria

Inclusion Criteria:

  • BMI < 35 kg/m2
  • LVEF > 40%
  • Exercise stress
  • Elective out-patients
  • No known CAD (>50%) by catheterization
  • No history of prior myocardial infarction

Exclusion Criteria:

  • LBBB
  • Pacemaker
  • Atrial Fibrillation
  • Frequent PAC's or PVC's
  • Inability to achieve at least 6 minutes
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01373944

Locations
United States, Missouri
Saint Luke's Cardiovascular Imaging Center
Kansas City, Missouri, United States, 64111
Saint Luke's North Cardiovascular Imaging Center
Kansas City, Missouri, United States, 64154
Saint Luke's East Cardiovascular Imaging Center
Lee's Summit, Missouri, United States, 64086
Sponsors and Collaborators
Aspire Foundation
Spectrum Dynamics
Cardiovascular Imaging Technologies, LLC
Saint Luke's Cardiovascular Consultants
Mid America Heart Institute
Investigators
Principal Investigator: Timothy M Bateman, MD Aspire Foundation
  More Information

No publications provided

Responsible Party: Timothy M. Bateman, MD, Medical Director, Aspire Foundation
ClinicalTrials.gov Identifier: NCT01373944     History of Changes
Other Study ID Numbers: D-Spect Stress Only
Study First Received: June 14, 2011
Last Updated: March 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Aspire Foundation:
MPI
SPECT
Stress-Only
Spectrum Dynamics Camera
Anger

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 May 16, 2013