Study Results
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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TERMINATED
125 participants
OBSERVATIONAL
2014-01-31
2017-05-01
Brief Summary
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Detailed Description
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Arm 1: Participants will be enrolled in this arm if they have been referred to the Gill Heart Institute MRI center for diagnostic late gadolinium enhancement (LGE) -CMR imaging of fibrosis, or if they are a healthy volunteer.
If a participant is a Gill Heart Institute referral patient , they will receive an intravenous (through a vein in the arm) infusion of gadolinium as part of their clinical examination. Participants will also have electrocardiogram (ECG) waveform performed in order to gate the MRI scan. The MRI scan of the heart, for which the participant has been referred will last approximately 1 hour. Participants will have an additional 5-10 minutes of scans performed, none of which require additional infusions.
If the participant is a healthy volunteer, they will have an ECG waveform performed in order to gate your MRI scan, and they will have approximately 30-45 minutes of scanning performed on their heart. Participants will not receive an infusion of gadolinium.
Arm 2: Only participants who are already participating in a study being conducted by Dr. Harmut Malluche at the University of Kentucky, Department of Nephrology or, if you are a healthy volunteer, will be enrolled into this arm.
In this arm participants will receive an MRI of their heart, lasting 30-45 minutes. Participants will not receive an infusion of gadolinium.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Arm 1 Mycardial Fibrosis
MRI with Intravenous administration of gadolinium
Arm 1 MRI with gadolinium
Healthy volunteers will not receive gadolinium
Arm 2 Chronic Kidney Disease
MRI with no gadolinium administration
No interventions assigned to this group
Interventions
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Arm 1 MRI with gadolinium
Healthy volunteers will not receive gadolinium
Eligibility Criteria
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Inclusion Criteria
* Diagnosis or suspicion of myocardial fibrosis
* Referral for LGE-CMR
* Participants between the ages of 20 and 80
* History of between 1-10 years of routine hemodialysis
* Healthy Volunteers
Exclusion:
* Confirmed acute myocardial infarction within the prior 72 hours
* Unstable ECG or arrhythmia
* Inability to hold one's breath for at least 10 seconds
Exclusion Criteria
* Unstable ECG or arrhythmia as determined by the referring physician
* Inability to hold one's breath for at least 10 seconds
* Allergic reaction to Gadolinium
* Women who are pregnant, think they are pregnant or who breastfeeding
Arm 2
20 Years
80 Years
ALL
Yes
Sponsors
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Moriel Vandsburger
OTHER
Responsible Party
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Moriel Vandsburger
Sponsor PI
Principal Investigators
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Moriel Vandsburger, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Kentucky, Department of Physiology
Locations
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University of Kentucky Medical Center
Lexington, Kentucky, United States
Countries
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Other Identifiers
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