Molecular MRI of the Fibrotic Heart

N/ATerminatedNCT02012725

Moriel Vandsburger125 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

125

Conditions

Healthy Myocardial Fibrosis Chronic Kidney Disease

Interventions

Arm 1 MRI with gadoliniumDRUG

Healthy volunteers will not receive gadolinium

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Kentucky Medical Center

Lexington, Kentucky, United States

Outcomes

Primary Outcomes

Arm 1 - Validation of gadolinium free fibrosis imaging against current standard of care LGE-CMR

Results from this arm will focus on validating cine FI measured from MT-weighted bSSFP cine CMR against LGE-CMR and MOLLI characterization of fibrosis in patients referred to the Gill Heart Institute.

Time frame: 36 months

Arm 2 - Imaging of myocardial fibrosis in CKD patients

Will test the hypothesis that MT-weighted CMR can be applied to identify fibrotic remodeling in the hearts of CKD5 patients

Time frame: 48 months

Data from ClinicalTrials.gov

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