Fibrosis in Chronic and Delayed Myocardial Infarction

Last updated: January 8, 2026
Sponsor: University of Edinburgh
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Disease

Occlusions

Coronary Artery Disease

Treatment

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

Clinical Study ID

NCT05756608
300754
  • Ages 40-90
  • All Genders
  • Accepts Healthy Volunteers

Study 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

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 noobstruction of ventricular outflow)

  • 10 healthy volunteers (no other significant co-morbidities, as assessed by the studyPI)

Cohort 2 (Chemotherapy-induced cardiotoxicity):

  • Male or female over the age of 35 years with evidence of cardiotoxicity on cardiacMRI (performed as part of the Cardiac care study), at least 1 year afteranthracycline treatment.

  • 10 patients over the age of 35 years (male or females) without evidence of fibrosison their 1-year scan after anthracycline treatment.

  • 10 healthy volunteers (>35 years of age) with no significant co-morbidities, asassessed 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 theage of 35 years, diagnosed as per consensus guidelines

  • Provision of informed consent prior to any study specific procedures

Exclusion

Exclusion Criteria:

  • Inability or unwilling to give informed consent.

  • History of claustrophobia or feeling of inability to tolerate supine position forthe 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.

Study Design

Total Participants: 180
Treatment Group(s): 1
Primary Treatment: 68Ga-FAPI and 18F-AlF-FAPI PET-MR
Phase:
Study Start date:
November 10, 2022
Estimated Completion Date:
August 31, 2028

Study Description

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.

Connect with a study center

  • University of Edinburgh

    Edinburgh, Scotland NE7 7EY
    United Kingdom

    Site Not Available

  • University of Edinburgh

    Edinburgh 2650225, Scotland 2638360 NE7 7EY
    United Kingdom

    Active - Recruiting

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