Efficiency and Outcomes of Stress-Only Anger and D-SPECT Stress-Only SPECT MPI
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
1 other identifier
observational
500
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2010
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 14, 2011
CompletedFirst Posted
Study publicly available on registry
June 15, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedDecember 23, 2013
December 1, 2013
1.7 years
June 14, 2011
December 20, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Diagnostic Failure
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.
30 days
Secondary Outcomes (4)
Necessity to proceed to a rest image
30 days
Necessity for additional downstream testing
30 days
Coronary Angiography
60 to 90 days
Determine optimal performance of the Spectrum Dynamics camera system for stress only imaging
60 to 90 days
Study Arms (2)
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 Criteria
Consecutive patients referred for clinically-indicated myocardial perfusion SPECT
You may qualify if:
- BMI \< 35 kg/m2
- LVEF \> 40%
- Exercise stress
- Elective out-patients
- No known CAD (\>50%) by catheterization
- No history of prior myocardial infarction
You may not qualify if:
- LBBB
- Pacemaker
- Atrial Fibrillation
- Frequent PAC's or PVC's
- Inability to achieve at least 6 minutes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aspire Foundationlead
- Spectrum Dynamicscollaborator
- Cardiovascular Imaging Technologies, LLCcollaborator
- Saint Luke's Cardiovascular Consultantscollaborator
- Mid America Heart Institutecollaborator
Study Sites (3)
Saint Luke's Cardiovascular Imaging Center
Kansas City, Missouri, 64111, United States
Saint Luke's North Cardiovascular Imaging Center
Kansas City, Missouri, 64154, United States
Saint Luke's East Cardiovascular Imaging Center
Lee's Summit, Missouri, 64086, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Timothy M Bateman, MD
Aspire Foundation
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 14, 2011
First Posted
June 15, 2011
Study Start
May 1, 2010
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
December 23, 2013
Record last verified: 2013-12