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Study finishedN/A

Fibrosis in Chronic and Delayed Myocardial Infarction

Sponsor: University of Edinburgh

NCT ID: NCT05756608

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
68Ga-FAPI and 18F-AlF-FAPI PET-MR (diagnostic test)
How long the study runs
Study runs about 44 months (dates as stated)
About the drug or intervention
68Ga-FAPI and 18F-AlF-FAPI PET-MR — diagnostic test: Hybrid Cardiac PET-MR with 68Ga-FAPI and 18F-AlF-FAPI radiotracer
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
40 Years to 90 Years
Who
All
Number of participants
50
Started
2022-11-10
Last checked
2026-08

Plain English Summary

What is this study?

  • • Testing a new treatment for aortic stenosis
  • • Clinical study - 50 participants
  • • 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

Who can take part?

  • • Ages 40 Years to 90 Years
  • • Diagnosed with aortic stenosis

Where?

  • • Edinburgh - University of Edinburgh

This is a simplified summary. Always discuss with your doctor before making any decisions.

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.

More detail

The investigators aim to investigate the role of fibrosis activity using 68Ga-FAPI and 18F-AlF-FAPI PET in chronic and delayed valvular, myocardial and endocardial injury states, in particular aortic stenosis, chemotherapy induced cardiotoxicity and carcinoid heart disease. The investigators also aim to analyse serum markers of myocardial injury and fibrosis at different time-points in these patient cohorts. Research Hypothesis 1. In patients with aortic stenosis, myocardial fibrosis activity will correlate with markers of left ventricular decompensation and aortic valve fibrosis activity, will predict progression in fibrosis burden and will decline following aortic valve replacement. 2. Increased myocardial fibrosis activity will be observed in the early stages of anthracycline- induced cardiotoxicity and will predict later deterioration in cardiac function. 3. In patients with carcinoid syndrome, increased endocardial fibrosis activity will be observed in patients with subclinical and clinically significant valve involvement.

Aortic StenosisChemotherapy Induced Systolic DysfunctionCarcinoid Syndrome

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 40 Years - 90 Years
  • Who can join: All genders

Biomarkers mentioned

eGFR

What the study is looking for

  • ✓Cohort 1(Aortic stenosis):
  • ✓Male or female above the age of 50 years old
  • ✓Provision of agreement to take part prior to any study specific procedures
  • ✓25 patients with causing symptoms severe aortic stenosis (peak velocity \>4.0 m/s)
  • ✓25 patients with moderate aortic stenosis (peak velocity 3.0-4.0 m/s)

Who cannot take part

  • ✗Inability or unwilling to give agreement to take part.
  • ✗History of claustrophobia or feeling of inability to tolerate supine position for the MRI scans.
  • ✗Impaired kidney function with eGFR of \<30 mL/min/1.73m2.
  • ✗Women who are pregnant or breastfeeding.
  • ✗Contrast allergy
See the full 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.

Where Is This Study? (1 UK site)

University of Edinburgh

Edinburgh NE7 7EY, United Kingdom

Hospital R&D contact (matched)

Accord Office

enquiries@accord.scot0131 242 3330
Data sourced from ClinicalTrials.gov · Last verified: 2026-08