Clinical trial NCT02012725: Molecular MRI of the Fibrotic Heart
Official title: Molecular MRI of the Fibrotic Heart
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Healthy
Myocardial Fibrosis
Chronic Kidney Disease
Keywords: Healthy
Myocardial fibrosis
Chronic kidney disease
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2013-12-16
Enrollment: 125
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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)

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Arm 1 - Validation of gadolinium free fibrosis imaging against current standard of care LGE-CMR
timeFrame: 36 months
measure: Arm 2 - Imaging of myocardial fibrosis in CKD patients
timeFrame: 48 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
Study officials:
affiliation: University of Kentucky, Department of Physiology
name: Moriel Vandsburger, PhD
role: PRINCIPAL_INVESTIGATOR
References: