Clinical trial NCT01150578: Evaluation of Myocardial Ischemia Using Standard Single Photon Emission Computed Tomography (SPECT) With Regadenoson and Simultaneous Cardiac Echocardiography
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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myocardial Ischemia
Keywords: Echocardiography, 2D
speckle tracking
Lexiscan
regadenoson
Myocardial ischemia
Myocardial perfusion imaging
cost and cost analysis
Cardiac-Gated SPECT Imaging
Echocardiography
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: Astellas Pharma US, Inc.
First posted: 2010-06-25
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: 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).
timeFrame: 10 minutes
Secondary outcomes:
measure: Obtain short term (6 month) outcomes: hospitalization for ischemia or infarction, coronary angiographic (invasive or noninvasive) correlation when available for clinical indications, and mortality.
timeFrame: 6 months
measure: Perform a limited cost-analysis of the two diagnostic testing options
timeFrame: 6 months
measure: Obtain hemodynamic Doppler Echo variables to investigate the acute hemodynamic alterations during Lexiscan infusion.
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona Medical Center
state: Arizona
Study officials:
affiliation: Associate Professor of Medicine and Radiology
name: Aiden Abidov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: