NCT05756608 Fibrosis in Chronic and Delayed Myocardial Infarction
| NCT ID | NCT05756608 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Edinburgh |
| Condition | Aortic Stenosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 180 participants |
| Start Date | 2022-11-10 |
| Primary Completion | 2028-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 180 participants in total. It began in 2022-11-10 with a primary completion date of 2028-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Marc Dweck, MBBS PhD
STUDY CHAIR
University of Edinburgh
Frequently Asked Questions
Who can join the NCT05756608 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 90 Years, studying Aortic Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05756608 currently recruiting?
Yes, NCT05756608 is actively recruiting participants. Contact the research team at kloganat@ed.ac.uk for enrollment information.
Where is the NCT05756608 trial being conducted?
This trial is being conducted at Edinburgh, United Kingdom.
Who is sponsoring the NCT05756608 clinical trial?
NCT05756608 is sponsored by University of Edinburgh. The principal investigator is Marc Dweck, MBBS PhD at University of Edinburgh. The trial plans to enroll 180 participants.