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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01373944
• Other study ID #: D-Spect Stress Only
• Status: Completed
• Phase: N/A
• First received: June 14, 2011
• Last updated: December 20, 2013
• Start date: May 2010
• Est. completion date: January 2012

Study information

• Verified date: December 2013
• Source: Aspire Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
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	Saint Luke's East Cardiovascular Imaging Center	Lee's Summit	Missouri

Sponsors (5)

Lead Sponsor	Collaborator
Aspire Foundation	Cardiovascular Imaging Technologies, LLC, Mid America Heart Institute, Saint Luke's Cardiovascular Consultants, Spectrum Dynamics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Necessity to proceed to a rest image	The first of 4 secondary end-points is the need to proceed to a rest image.	30 days	No
Secondary	Necessity for additional downstream testing	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.	30 days	No
Secondary	Coronary Angiography	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.	60 to 90 days	No
Secondary	Determine optimal performance of the Spectrum Dynamics camera system for stress only imaging	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	60 to 90 days	No