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Recruiting
NCT05756608
Fibrosis in Chronic and Delayed Myocardial Infarction
Conditions: Aortic Stenosis, Chemotherapy Induced Systolic Dysfunction, Carcinoid Syndrome
Sex: All
Ages: 40 Years – 90 Years
Healthy volunteers: 1
Enrollment: 180
Sponsor: University of Edinburgh
Location: United Kingdom
Summary
In this study the investigators aim to examine the role that fibrosis plays in heart conditions such as aortic stenosis , chemotherapy-induced cardiotoxicity and carcinoid syndrome .
Fibrosis is a common final result following any injury to the heart muscle and the investigators aim to identify this process early and in its active state.
This will be examined by using a radiotracer 68Ga-FAPI or 18F-AlF-FAPI and PET-MRI or PET-CT.
Eligibility Criteria
Inclusion Criteria:Cohort 1(Aortic stenosis):Male or female above the age of 50 years oldProvision of informed consent prior to any study specific procedures25 patients with symptomatic severe aortic stenosis (peak velocity >4.0 m/s)25 patients with moderate aortic stenosis (peak velocity 3.0-4.0
m/s)10 patients with mild aortic stenosis (peak velocity 2.6-2.9 m/s)10 patients with aortic sclerosis (tri-leaflet thickened aortic valve with no obstruction of ventricular outflow)10 healthy volunteers (no other significant co-morbidities, as assessed by the study PI)Cohort 2 (Chemotherapy-induced cardiotoxicity):Male or female over the age of 35 years with evidence of cardiotoxicity on cardiac MRI (performed as part of the Cardiac care study), at least 1 year after anthracycline treatment.10 patients over the age of 35 years (male or females) without evidence of fibrosis on their 1-year scan after anthracycline treatment.10 healthy volunteers (>35 years of age) with no significant co-morbidities, as assessed by the study PI.Provision of informed consent prior to any study specific proceduresCohort 3 (Carcinoid syndrome):30 patients with carcinoid syndrome (with or without cardiac involvement), over the age of 35 years, diagnosed as per consensus guidelinesProvision of informed consent prior to any study specific proceduresExclusion Criteria:Inability or unwilling to give informed consent.History of claustrophobia or feeling of inability to tolerate supine position for the MRI scans.Impaired renal function with eGFR of <30 mL/min/1.73m2.Women who are pregnant or breastfeeding.Contrast allergyContraindication to cardiac MRI (e.g.
metallic implant or severe claustrophobia)Recent myocardial infarction, other known causes of cardiomyopathy/cardiac fibrosis.
Source: ClinicalTrials.gov (NCT05756608). StuddyBuddy aggregates publicly available trial information.