Molecular MRI of the Fibrotic Heart

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.

Study Overview

• Status: Terminated
• Conditions: Myocardial Fibrosis; Healthy; Chronic Kidney Disease
• Intervention / Treatment: Drug: Arm 1 MRI with gadolinium

Detailed 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 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 (Actual): 125

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Participants taking part in this study will be:

• Referred from the University of Kentucky Gill Heart Institute (planned enrollment for this group is 100 patients)
• Referred from another study on chronic kidney disease (planned enrollment for this group is 100 patients and 50 healthy volunteers)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Arm 1 Mycardial Fibrosis; MRI with Intravenous administration of gadolinium	Drug: Arm 1 MRI with gadolinium; Healthy volunteers will not receive gadolinium
Arm 2 Chronic Kidney Disease; MRI with no gadolinium administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	48 months

Collaborators and Investigators

• Sponsor: Moriel Vandsburger
• Investigators: Principal Investigator: Moriel Vandsburger, PhD, University of Kentucky, Department of Physiology

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: December 6, 2013
• First Submitted That Met QC Criteria: December 10, 2013
• First Posted (Estimate): December 16, 2013

Study Record Updates

• Last Update Posted (Actual): January 23, 2018
• Last Update Submitted That Met QC Criteria: January 18, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Healthy; Chronic kidney disease; Myocardial fibrosis
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Renal Insufficiency; Fibrosis; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: 5KL2TR000116-03 (U.S. NIH Grant/Contract)