Evaluation of Myocardial Ischemia Using Standard Single Photon Emission Computed Tomography (SPECT) With Regadenoson and Simultaneous Cardiac Echocardiography

Brief Summary

Official Title: “Lexi-Echo – a Rapid, Portable, Non-radiating Diagnostic Test for Myocardial Ischemia That is Accurate Relative to Simultaneously Obtained Nuclear SPECT MPI”

This study is for people who have a SPECT scan (nuclear imaging of the blood flow to the heart muscle) ordered by their medical doctors. As part of the SPECT scan, they will have been given a drug called regadenoson to widen and expand the blood vessels bringing blood to the heart muscle. The SPECT pictures of the heart are taken about an hour after the regadenoson is put into an arm vein through an IV. In this study, additional echo pictures will be taken and compared to the SPECT pictures.

The aim of the study is to see if the echo pictures work as well as SPECT to measure the blood flow to the heart muscle.

  • Study Type: Observational
  • Study Design: Observational Model: Cohort, Time Perspective: Prospective
  • Study Primary Completion Date: November 2014

Detailed Clinical Trial Description

This is a single center, prospective, non-randomized, comparative, same-setting study of Lexiscan MPI SPECT versus state-of-the-art echocardiography. Lexiscan SPECT MPI will be performed per routine clinical protocol with Lexiscan administered as per package insert (0.4 mg in 5 ml IV push over 10 seconds followed by a 5 ml saline flush). Simultaneous echo/Doppler will be obtained immediately before (baseline), during and immediately post (peak vasodilation) using conventional techniques.

Interventions Used in this Clinical Trial

  • Drug: No intervention
    • No intervention

Arms, Groups and Cohorts in this Clinical Trial

  • Lexi-Echo pilot
    • Appropriate patients at University of Arizona Medical Center stress imaging laboratory who have a routine regadenoson SPECT nuclear scan will have simultaneous cardiac echo images obtained.

Outcome Measures for this Clinical Trial

Primary Measures

  • Determine the diagnostic accuracy of state-of-the-art echocardiography after regadenoson administration (Lexi-Echo) in the evaluation of myocardial ischemia (determined by the reference standard myocardial perfusion imaging SPECT).
    • Time Frame: 10 minutes
      Safety Issue?: No

Secondary Measures

  • Obtain short term (6 month) outcomes: hospitalization for ischemia or infarction, coronary angiographic (invasive or noninvasive) correlation when available for clinical indications, and mortality.
    • Time Frame: 6 months
      Safety Issue?: No
  • Perform a limited cost-analysis of the two diagnostic testing options
    • Time Frame: 6 months
      Safety Issue?: No
  • Obtain hemodynamic Doppler Echo variables to investigate the acute hemodynamic alterations during Lexiscan infusion.
    • Time Frame: 10 minutes
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria

  • Patients referred to a University of Arizona/Sarver Heart Center/University Medical Center stress imaging laboratory and scheduled to receive a regadenoson SPECT nuclear scan.

Exclusion Criteria

  • Patients unable or unwilling to undergo the clinically necessary stress test or to provide informed consent.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Aiden Abidov
  • Collaborator
    • Astellas Pharma US, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Aiden Abidov, Associate Professor of Medicine and Radiology – University of Arizona
  • Overall Official(s)
    • Aiden Abidov, MD, PhD, Principal Investigator, Associate Professor of Medicine and Radiology

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01150578