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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 below
Select...
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 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

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
91 Previous Clinical Trials
74,806 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
University Health Network, TorontoLead Sponsor
1,531 Previous Clinical Trials
504,072 Total Patients Enrolled
1 Trials studying Fabry Disease
5 Patients Enrolled for Fabry Disease
Vancouver General HospitalOTHER
41 Previous Clinical Trials
19,425 Total Patients Enrolled
The Cleveland ClinicOTHER
1,057 Previous Clinical Trials
1,371,510 Total Patients Enrolled
Icahn School of Medicine at Mount SinaiOTHER
914 Previous Clinical Trials
572,651 Total Patients Enrolled
Mayo ClinicOTHER
3,362 Previous Clinical Trials
3,065,731 Total Patients Enrolled
University of Colorado, DenverOTHER
1,810 Previous Clinical Trials
2,919,850 Total Patients Enrolled
Kate HannemanPrincipal InvestigatorUniversity Health Network, Toronto
1 Previous Clinical Trials
251 Total Patients Enrolled

Media Library

Cardiac MRI (Diagnostic Test) Clinical Trial Eligibility Overview. Trial Name: NCT04856059 — N/A
Fabry Disease Research Study Groups: Cardiac MRI, ECG and Blood Biomarkers
Fabry Disease Clinical Trial 2023: Cardiac MRI Highlights & Side Effects. Trial Name: NCT04856059 — N/A
Cardiac MRI (Diagnostic Test) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04856059 — N/A
~91 spots leftby Dec 2026
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