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Diagnostic Test
Multiparametric MRI for Fabry Cardiomyopathy (FIESTA-MRI Trial)
N/A
Recruiting
Led By Kate Hanneman
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with Fabry disease
Age ≥ 18 years
Must not have
History of myocardial infarction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will test whether using MRI to map the heart can help doctors detect abnormalities in patients with Fabry disease and identify those at risk for serious problems.
Who is the study for?
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.
What is being tested?
The study tests if advanced cardiac MRI techniques can spot early signs of heart damage in Fabry patients and predict future complications better than traditional methods.
What are the potential side effects?
Cardiac MRI is generally safe but may cause discomfort, anxiety, or claustrophobia. Rarely, allergic reactions to contrast agents used during the scan can occur.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have Fabry disease.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had a heart attack before.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Major Adverse Cardiac Events (MACE)
Secondary study objectives
The FAbry STabilization indEX (FASTEX) score
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Cardiac MRI, ECG and Blood BiomarkersExperimental Treatment1 Intervention
Additional sequences will be performed during routine clinical cardiac MRI and additional blood samples will be collected during routine blood work.
Find a Location
Who is running the clinical trial?
IRCCS Policlinico S. DonatoOTHER
90 Previous Clinical Trials
74,768 Total Patients Enrolled
Alberta Health servicesOTHER
163 Previous Clinical Trials
652,408 Total Patients Enrolled
Libin Cardiovascular Institute of AlbertaOTHER
3 Previous Clinical Trials
398 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a heart attack before.I have Fabry disease.You cannot have an MRI for medical reasons.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Cardiac MRI, ECG and Blood Biomarkers
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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