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

Myocardial Ischemia Clinical Trial

— Lexi-Echo  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01150578
• Other study ID #: Lexi-Echo2010
• Status: Active, not recruiting
• Phase: N/A
• First received: March 9, 2010
• Last updated: November 3, 2015
• Start date: December 2011
• Est. completion date: December 2015

Study information

• Verified date: November 2015
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 380
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Ischemia
• Myocardial Ischemia

Intervention

Drug:
• No intervention
No intervention

Locations

Country	Name	City	State
United States	University of Arizona Medical Center	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Aiden Abidov	Astellas Pharma US, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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