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
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View full resultsBasic Information
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COMPLETED
PHASE4
40 participants
INTERVENTIONAL
2014-09-03
2018-03-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Regadenoson
Regadenoson is a single-use, pre-filled syringe containing 0.4 mg/5 mL of regadenoson.
Regadenoson
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
19 Years
90 Years
ALL
Yes
Sponsors
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Saint Luke's Health System
OTHER
Saint Luke's Cardiovascular Consultants
OTHER
Timothy M. Bateman
OTHER
Responsible Party
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Timothy M. Bateman
Medical Director
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
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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Astellas CMR Tagging
Identifier Type: -
Identifier Source: org_study_id
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