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

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT01373944
• Lead Sponsor: Aspire Foundation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2011-06-14
• Study First Submitted QC: 2011-06-14
• Study First Posted: 2011-06-15
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-20
• Last Update Posted: 2013-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic Failure	30 days	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

Name	Time	Method
Necessity to proceed to a rest image	30 days	The first of 4 secondary end-points is the need to proceed to a rest image.
Necessity for additional downstream testing	30 days	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	60 to 90 days	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	60 to 90 days	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

Trial Locations

Locations (3)

Saint Luke's East Cardiovascular Imaging Center; 🇺🇸 Lee's Summit, Missouri, United States

Saint Luke's Cardiovascular Imaging Center; 🇺🇸 Kansas City, Missouri, United States

Saint Luke's North Cardiovascular Imaging Center; 🇺🇸 Kansas City, Missouri, United States