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OpenTrials
Completed

NCT Number: NCT00976053

Effectiveness Study of Single Photon Emission Computed Tomography (SPECT) Versus Positron Emission Tomography (PET) Myocardial Perfusion Imaging

The purpose of this study is to compare pharmacologic stress myocardial perfusion PET with pharmacologic stress myocardial perfusion SPECT in a near-simultaneous, head-to-head comparison in the same patient. The investigators hypothesize that pharmacologic stress myocardial perfusion PET will prove superior to pharmacologic stress myocardial perfusion SPECT as a first-line diagnostic test for higher-risk patients with known coronary artery disease (CAD) who present with symptoms consistent with possible worsening of their CAD.

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Key information

Age range

30 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Saint Luke's Cardiovascular Consultants

Kansas City, Missouri, 64111, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • History of coronary artery disease
  • New or worsening symptoms
  • Out-patients and in-hospital patients

Exclusion criteria

  • Creatinine above 2.5 mg%
  • PCI within prior 6 months
  • Pregnant females
  • Cardiomyopathy (LVEF below 40%)
  • Significant valvular heart disease
  • Body mass index greater than 38

Treatment and study plan

Myocardial perfusion imaging

Procedure

Randomization assignment to one of SPECT or PET myocardial perfusion imaging

Primary outcomes

  1. Diagnostic failure of SPECT vs PET

    Time frame: 60 days

Secondary outcomes

  1. Composite of diagnostic or clinical failure

    Time frame: 12 months

  2. Each of individual components of clinical failure

    Time frame: 12 months

  3. Relative effect on quality of life

    Time frame: 3 months, 6 months

  4. Relative direct and downstream costs

    Time frame: 3 months, 6 months, 12 months

Sponsors and collaborators

Lead sponsor

Aspire Foundation

Other

Collaborators

  • Blue Cross Blue Shield
  • Cardiovascular Imaging Technologies
  • Mid America Heart Institute
  • Saint Luke's Cardiovascular Consultants

Registry information

Official study title

Clinical Effectiveness of Pharmacologic Stress Radionuclide Myocardial Perfusion Imaging as a Guide to Management of Patients With Known CAD: Comparison of Single-Photon Emission Computed Tomography (SPECT) and Positron Emission Tomography (PET)

Important dates

Study start
2009
Primary completion
2013
Study completion
2014
First posted
Sep 14, 2009
Registry last updated
Oct 31, 2014

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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