Evaluation of Myocardial Ischemia Using Standard Single Photon Emission Computed Tomography (SPECT) With Regadenoson and Simultaneous Cardiac Echocardiography (Lexi-Echo)
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 Design:||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|
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Perform a limited cost-analysis of the two diagnostic testing options [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Obtain hemodynamic Doppler Echo variables to investigate the acute hemodynamic alterations during Lexiscan infusion. [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]
|Study Start Date:||December 2011|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
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
Other Name: No intervention
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01150578
|United States, Arizona|
|University of Arizona Medical Center|
|Tucson, Arizona, United States, 85724|
|Principal Investigator:||Aiden Abidov, MD, PhD||Associate Professor of Medicine and Radiology|