Recruitment

Recruitment Status
Terminated
Estimated Enrollment
250

Inclusion Criterias

History of between 1-10 years of routine hemodialysis
Participants between the ages of 20 and 80
Healthy Volunteers
History of between 1-10 years of routine hemodialysis
Participants between the ages of 20 and 80
Healthy Volunteers

Exclusion Criterias

Standard MRI safety exclusion criteria
Confirmed acute myocardial infarction within the prior 72 hours
Unstable ECG or arrhythmia
...
Standard MRI safety exclusion criteria
Confirmed acute myocardial infarction within the prior 72 hours
Unstable ECG or arrhythmia
Inability to hold one's breath for at least 10 seconds

Summary

Conditions
  • Chronic Kidney Disease
  • Healthy
  • Myocardial Fibrosis
Type
Observational
Design
  • Observational Model: Case-Control
  • Time Perspective: Prospective

Participation Requirements

Age
Between 20 years and 80 years
Gender
Both males and females

Description

This study had two treatment arms. 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 Instit...

This study had two treatment arms. 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.

Inclusion Criterias

History of between 1-10 years of routine hemodialysis
Participants between the ages of 20 and 80
Healthy Volunteers
History of between 1-10 years of routine hemodialysis
Participants between the ages of 20 and 80
Healthy Volunteers

Exclusion Criterias

Standard MRI safety exclusion criteria
Confirmed acute myocardial infarction within the prior 72 hours
Unstable ECG or arrhythmia
...
Standard MRI safety exclusion criteria
Confirmed acute myocardial infarction within the prior 72 hours
Unstable ECG or arrhythmia
Inability to hold one's breath for at least 10 seconds

Locations

Lexington, Kentucky, 40536
Lexington, Kentucky, 40536

Tracking Information

NCT #
NCT02012725
Collaborators
Not Provided
Investigators
  • Principal Investigator: Moriel Vandsburger, PhD University of Kentucky, Department of Physiology
  • Moriel Vandsburger, PhD University of Kentucky, Department of Physiology