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

NCT ID: NCT01150578

Last Updated: 2015-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

380 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-12-31

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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Myocardial Ischemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No intervention

Intervention Type DRUG

No intervention

Interventions

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No intervention

No intervention

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma US, Inc.

INDUSTRY

Sponsor Role collaborator

Aiden Abidov

OTHER

Sponsor Role lead

Responsible Party

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Aiden Abidov

Associate Professor of Medicine and Radiology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Aiden Abidov, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor of Medicine and Radiology

Locations

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University of Arizona Medical Center

Tucson, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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Lexi-Echo2010

Identifier Type: -

Identifier Source: org_study_id

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