Multiparametric MRI for Fabry Cardiomyopathy
(FIESTA-MRI Trial)
Trial Summary
Do I need to stop my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Cardiac MRI for Fabry Cardiomyopathy?
Is cardiac MRI safe for humans?
How is cardiac MRI used as a treatment for Fabry cardiomyopathy different from other treatments?
Cardiac MRI is unique for Fabry cardiomyopathy because it is a noninvasive imaging technique that helps diagnose and monitor the disease by assessing heart structure and function, and detecting early signs of heart involvement, unlike other treatments that may focus on managing symptoms or enzyme replacement.2341112
What is the purpose of this trial?
This study will evaluate whether cardiac MRI T1 and T2 mapping improves our ability to detect early abnormalities in the heart in patients with Fabry disease and identify patients at increase risk of adverse events.
Research Team
Kate Hanneman, MD
Principal Investigator
University Health Network, Toronto
Eligibility Criteria
This trial is for adults over 18 with Fabry disease, aiming to detect early heart issues. It's not suitable for those who've had a heart attack or can't undergo MRI scans due to health risks or implanted medical devices.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Cardiac MRI and Biomarker Assessment
Participants undergo cardiac MRI, ECG, and blood biomarker assessments to detect early myocardial abnormalities
Follow-up
Participants are monitored for major adverse cardiac events and changes in the FASTEX score
Treatment Details
Interventions
- Cardiac MRI
Cardiac MRI is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
- Congenital heart disease
- Cardiomyopathies
- Valvular heart disease
- Diseases of the aorta
- Coronary heart disease
- Cardiac tumors
- Coronary heart disease
- Congenital heart defects
- Heart valve problems
- Pericarditis
- Cardiac tumors
- Myocardial infarction
- Cardiomyopathies
- Valvular heart disease
- Diseases of the aorta
- Coronary heart disease
- Cardiac tumors
- Myocardial infarction
- Congenital heart disease
- Cardiomyopathies
- Valvular heart disease
- Diseases of the aorta
- Coronary heart disease
- Congenital heart disease
- Cardiomyopathies
- Valvular heart disease
- Diseases of the aorta
- Coronary heart disease
- Congenital heart disease
- Cardiomyopathies
- Valvular heart disease
- Diseases of the aorta
- Coronary heart disease
Find a Clinic Near You
Who Is Running the Clinical Trial?
University Health Network, Toronto
Lead Sponsor
IRCCS Policlinico S. Donato
Collaborator
Alberta Health services
Collaborator
Libin Cardiovascular Institute of Alberta
Collaborator
Vancouver General Hospital
Collaborator
The Cleveland Clinic
Collaborator
Icahn School of Medicine at Mount Sinai
Collaborator
Mayo Clinic
Collaborator
University of Colorado, Denver
Collaborator