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

NCT01150578 | Unknown

• 1 other identifier: Lexi-Echo2010
• Study Type: observational
• Target: 380
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Ischemia

Keywords

Echocardiography, 2D; speckle tracking; Lexiscan; regadenoson; Myocardial ischemia; Myocardial perfusion imaging; cost and cost analysis; Cardiac-Gated SPECT Imaging; Echocardiography

Outcome Measures

Primary Outcomes (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).

  10 minutes

Secondary Outcomes (3)

• 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

• Perform a limited cost-analysis of the two diagnostic testing options

  6 months

• Obtain hemodynamic Doppler Echo variables to investigate the acute hemodynamic alterations during Lexiscan infusion.

  10 minutes

Study Arms (1)

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

Interventions

No intervention DRUG

No intervention

Lexi-Echo pilot

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Aiden Abidov: lead
• Astellas Pharma US, Inc.: collaborator

Study Sites (1)

University of Arizona Medical Center

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Aiden Abidov, MD, PhD

  Associate Professor of Medicine and Radiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine and Radiology

Study Record Dates

• First Submitted: March 9, 2010
• First Posted: June 25, 2010
• Study Start: December 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: November 4, 2015

Record last verified: 2015-11

Locations

US (1)