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Completed

NCT Number: NCT01373944

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Diagnostic Failure

    Time frame: 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 outcomes

  1. Necessity to proceed to a rest image

    Time frame: 30 days

    The first of 4 secondary end-points is the need to proceed to a rest image.

  2. Necessity for additional downstream testing

    Time frame: 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.

  3. Coronary Angiography

    Time frame: 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.

  4. Determine optimal performance of the Spectrum Dynamics camera system for stress only imaging

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Aspire Foundation

Other

Collaborators

  • Cardiovascular Imaging Technologies
  • Mid America Heart Institute
  • Saint Luke's Cardiovascular Consultants
  • Spectrum Dynamics

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jun 15, 2011
Registry last updated
Dec 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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