RECRUITINGOBSERVATIONAL
Fibrosis in Chronic and Delayed Myocardial Infarction
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