Molecular MRI of the Fibrotic Heart

Stopped early

Conditions studied: Healthy, Myocardial Fibrosis, Chronic Kidney Disease

In brief

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.

Key facts

Study ID

NCT02012725

Run by

Moriel Vandsburger

People needed

125

Starts

2014-01-01

Expected to finish

2017-05-01

Last updated by the study team

2018-01-23

Who can join

Age: 20 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Participants between the ages of 20 and 80
• Diagnosis or suspicion of myocardial fibrosis
• Referral for LGE-CMR

You may not qualify if…

• 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

Where it is running

• University of Kentucky Medical Center — Lexington, Kentucky, United States

Full record on ClinicalTrials.gov

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