Fibrosis in Chronic and Delayed Myocardial Infarction (NCT05756608) | Clinical Trial Compass
RecruitingNot Applicable
Fibrosis in Chronic and Delayed Myocardial Infarction
United Kingdom180 participantsStarted 2022-11-10
Plain-language 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.
Who can participate
Age range
40 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 feelin…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.