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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01373944

Enrollment

500

Registered

2011-06-15

Start date

2010-05-31

Completion date

2012-01-31

Last updated

2013-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

MPI, SPECT, Stress-Only, Spectrum Dynamics Camera, Anger

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
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.

Countries

United States

Outcome results