Characterization of Changes in Ventricular Mechanics in Response to Lexiscan Stress Using Tagged Cine Cardiac Magnetic Resonance Imaging

NCT ID: NCT02115308

Last Updated: 2018-09-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-03

Study Completion Date

2018-03-23

Brief Summary

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The purpose of this study is to measure the changes in cardiac function during a Lexiscan pharmacologic stress test using cardiac magnetic resonance imaging test.

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Regadenoson

Regadenoson is a single-use, pre-filled syringe containing 0.4 mg/5 mL of regadenoson.

Group Type OTHER

Regadenoson

Intervention Type DRUG

Regadenoson injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging.

Interventions

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Regadenoson

Regadenoson injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging.

Intervention Type DRUG

Other Intervention Names

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Lexiscan

Eligibility Criteria

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Inclusion Criteria

* Myocardial rest/regadenoson stress perfusion PET study within 60 days
* Normal rest LVEF (greater than or equal to 50%)
* No change in symptoms or treatment between the PET and the MRI study
* Willing to consent to the study
* Male or female who is either post-menopausal, surgically sterile, or if has a childbearing potential, a negative pregnancy test within 2 days prior to the MRI study.

Exclusion Criteria

* Renal dysfunction (estimated glomerular filtration rate \< 60 mL/min/1.73m2) within 6 months
* Metallic implants, pacemaker, blood vessel clip (contra-indicated for MRI)
* Patient size exceeds MRI bore/table limits: (Max body diameter \> 60 cm, weight \> 136 kg)
* History of gadolinium contrast allergy or intolerance
* Second or third degree AV block
* Sinus node dysfunction
* Acute myocardial infarction (past 3 months)
* Actively wheezing or with acute asthma or bronchospastic attacks requiring changes in therapy within the past 30 days
* Patients that have experienced a previous hypersensitivity reaction thought to be related to regadenoson
Minimum Eligible Age

19 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Saint Luke's Health System

OTHER

Sponsor Role collaborator

Saint Luke's Cardiovascular Consultants

OTHER

Sponsor Role collaborator

Timothy M. Bateman

OTHER

Sponsor Role lead

Responsible Party

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Timothy M. Bateman

Medical Director

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Timothy M Bateman, MD

Role: PRINCIPAL_INVESTIGATOR

Aspire Foundation

Locations

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Saint Luke's Health System

Kansas City, Missouri, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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Astellas CMR Tagging

Identifier Type: -

Identifier Source: org_study_id

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