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RECRUITINGOBSERVATIONAL

Fibrosis in Chronic and Delayed Myocardial Infarction

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: Cohort 1(Aortic stenosis): - Male or female above the age of 50 years old - Provision of willing to sign a consent form prior to any study specific procedures - 25 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 willing to sign a consent form prior to any study specific procedures Cohort 3 (Carcinoid syndrome): - 30 patients with carcinoid syndrome (with or without cardiac involvement), over the age of 35 years, diagnosed as per consensus guidelines - Provision of willing to sign a consent form prior to any study specific procedures Who Should NOT Join This Trial: - Inability or unwilling to give willing to sign a consent form. - 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 allergy - Contraindication to cardiac MRI (e.g. metallic implant or severe claustrophobia) - Recent myocardial infarction, other known causes of cardiomyopathy/cardiac fibrosis. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: Cohort 1(Aortic stenosis): * Male or female above the age of 50 years old * Provision of informed consent prior to any study specific procedures * 25 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 procedures Cohort 3 (Carcinoid syndrome): * 30 patients with carcinoid syndrome (with or without cardiac involvement), over the age of 35 years, diagnosed as per consensus guidelines * Provision of informed consent prior to any study specific procedures Exclusion 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 allergy * Contraindication to cardiac MRI (e.g. metallic implant or severe claustrophobia) * Recent myocardial infarction, other known causes of cardiomyopathy/cardiac fibrosis.

Treatments Being Tested

DIAGNOSTIC_TEST

68Ga-FAPI and 18F-AlF-FAPI PET-MR

Hybrid Cardiac PET-MR with 68Ga-FAPI and 18F-AlF-FAPI radiotracer

Locations (1)

University of Edinburgh
Edinburgh, Scotland, United Kingdom