Molecular MRI of the Fibrotic Heart

Healthy Clinical Trial

Official title:

Molecular MRI of the Fibrotic Heart

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02012725
• Other study ID #: 5KL2TR000116-03
• Status: Terminated
• Phase: N/A
• First received: December 6, 2013
• Last updated: January 18, 2018
• Start date: January 2014
• Est. completion date: May 1, 2017

Study information

• Verified date: January 2018
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 125
• Est. completion date: May 1, 2017
• Est. primary completion date: May 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Fibrosis
• Healthy
• Kidney Diseases
• Myocardial Fibrosis
• Renal Insufficiency, Chronic

Intervention

Drug:
• Arm 1 MRI with gadolinium
Healthy volunteers will not receive gadolinium

Locations

Country	Name	City	State
United States	University of Kentucky Medical Center	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Moriel Vandsburger

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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