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

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ClinicalTrials.gov Identifier: NCT01150578
Recruitment Status : Unknown
Verified November 2015 by Aiden Abidov, University of Arizona.
Recruitment status was:  Active, not recruiting
First Posted : June 25, 2010
Last Update Posted : November 4, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment
Myocardial Ischemia Drug: No intervention

Detailed 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.

Study Design

Study Type : Observational
Estimated Enrollment : 380 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Lexi-Echo - a Rapid, Portable, Non-radiating Diagnostic Test for Myocardial Ischemia That is Accurate Relative to Simultaneously Obtained Nuclear SPECT MPI
Study Start Date : December 2011
Primary Completion Date : December 2014
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Regadenoson
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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.
Drug: No intervention
No intervention


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Perform a limited cost-analysis of the two diagnostic testing options [ Time Frame: 6 months ]
  3. Obtain hemodynamic Doppler Echo variables to investigate the acute hemodynamic alterations during Lexiscan infusion. [ Time Frame: 10 minutes ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01150578


Locations
United States, Arizona
University of Arizona Medical Center
Tucson, Arizona, United States, 85724
Sponsors and Collaborators
Aiden Abidov
Astellas Pharma US, Inc.
Investigators
Principal Investigator: Aiden Abidov, MD, PhD Associate Professor of Medicine and Radiology
More Information

Responsible Party: Aiden Abidov, Associate Professor of Medicine and Radiology, University of Arizona
ClinicalTrials.gov Identifier: NCT01150578     History of Changes
Other Study ID Numbers: Lexi-Echo2010
First Posted: June 25, 2010    Key Record Dates
Last Update Posted: November 4, 2015
Last Verified: November 2015

Keywords provided by Aiden Abidov, University of Arizona:
Echocardiography, 2D
speckle tracking
Lexiscan
regadenoson
Myocardial ischemia
Myocardial perfusion imaging
cost and cost analysis
Cardiac-Gated SPECT Imaging
Echocardiography

Additional relevant MeSH terms:
Ischemia
Myocardial Ischemia
Coronary Artery Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Regadenoson
Adenosine A2 Receptor Agonists
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs