Molecular MRI of the Fibrotic Heart
| Status: | Terminated |
|---|---|
| Conditions: | Healthy Studies, Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Nephrology / Urology, Other |
| Healthy: | No |
| Age Range: | 20 - 80 |
| Updated: | 1/24/2018 |
| Start Date: | January 2014 |
| End Date: | May 1, 2017 |
This study is a feasibility study to validate magnetizatin transfer (MT)-weighted balanced
steady state free precession (bSSFP) cine cardiac magnetic resonance (CMR) against current
clinical gold standard diagnostics, and to determine the applicability of MT-weighted bSSFP
cine CMR for diagnosis of fibrotic remodeling in chronic kidney disease (CKD5) patients.
Participants will not receive a study drug or placebo and will not be randomized. A total of
250 participants will be enrolled into this study.
steady state free precession (bSSFP) cine cardiac magnetic resonance (CMR) against current
clinical gold standard diagnostics, and to determine the applicability of MT-weighted bSSFP
cine CMR for diagnosis of fibrotic remodeling in chronic kidney disease (CKD5) patients.
Participants will not receive a study drug or placebo and will not be randomized. A total of
250 participants will be enrolled into this study.
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.
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.
Arm 1
Inclusion Criteria:
- Participants between the ages of 20 and 80
- Diagnosis or suspicion of myocardial fibrosis
- Referral for LGE-CMR
Exclusion Criteria:
- Confirmed acute MI within the prior 72 hours
- Unstable ECG or arrhythmia as determined by the referring physician
- Inability to hold one's breath for at least 10 seconds
- Standard MRI safety exclusion criteria
- Allergic reaction to Gadolinium
- Women who are pregnant, think they are pregnant or who breastfeeding
Arm 2
Inclusion Criteria:
- 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
- Standard MRI safety exclusion criteria
We found this trial at
1
site
740 South Limestone Street
Lexington, Kentucky 40536
Lexington, Kentucky 40536
Principal Investigator: Moriel Vandsburger, PhD
Phone: 859-218-1704
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