Fibrosis in Chronic and Delayed Myocardial Infarction

NCT05756608 | Recruiting

• 1 other identifier: 300754
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Stenosis; Carcinoid Syndrome; Chemotherapy Induced Systolic Dysfunction

Outcome Measures

Primary Outcomes (2)

• Fibrosis activity: Standardised uptake values (SUV

  SUV

  1-2 years

• Fibrosis activity:Tissue-to-Background Ratio

  TBR

  1-2 years

Study Arms (3)

Aortic stenosis

The investigators will recruit 70 patients with aortic stenosis (25 patients with asymptomatic moderate aortic stenosis and 25 patients with symptomatic severe aortic stenosis, 10 patients with mild aortic stenosis and 10 patients with aortic sclerosis) and 10 healthy volunteers, who will undergo baseline 68Ga-FAPI or 18F-AlF-FAPI PET/MR imaging to establish fibrosis activity in healthy myocardium and in context of chronic myocardial injury. All patients will have a follow up FAPI PET/ MR scan 1 year after their baseline scan to assess whether myocardial fibrosis activity reverses following aortic valve replacement and restoration of normal afterload in patients with severe aortic stenosis and if baseline myocardial fibrosis activity can predict progression in the fibrosis burden and clinical progression in patients with mild or moderate aortic stenosis or aortic sclerosis. Healthy volunteers will not undergo any repeat imaging.

Diagnostic Test: 68Ga-FAPI and 18F-AlF-FAPI PET-MR

Chemotherapy-induced cardiotoxicity

The investigators will recruit 60 patients who have undergone anthracycline treatment \>1 year from enrollment and 10 healthy volunteers as part of this cohort. This will include 50 patients who have either clear evidence of cardiotoxicity (Ejection fraction \<50% and a 10%point fall in ejection fraction) or a subclinical cardiac injury (elevated troponin, elevated T2, impaired global longitudinal strain) and 10 patients with no evidence of cardiotoxicity on their cardiac MRI scan (performed as part of the ongoing Cardiac CARE study). These patients will undergo baseline FAPI PET/MR imaging to establish the extent and pattern of myocardial fibrosis activity in context of delayed myocardial injury (chemotherapy-induced cardiotoxicity). All patients will have a follow up cardiac MRI scan 1-2 years after their baseline scan to assess whether baseline fibrosis activity is associated with a deterioration in cardiac function. Healthy volunteers will not undergo any repeat imaging.

Diagnostic Test: 68Ga-FAPI and 18F-AlF-FAPI PET-MR

Carcinoid syndrome

In collaboration with the South East Scotland NET Service, the investigators will recruit 30 patients with carcinoid syndrome for this cohort. These patients will undergo a baseline echocardiogram and a FAPI PET/MR scan to investigate fibrosis activity within the cardiac chambers and valves. The investigators will recruit patients with established cardiac involvement as well as carcinoid syndrome patients with high circulating 5-HT concentrations who have no evidence of valve disease on echocardiography. All patients will have a follow up cardiac MRI scan and an echocardiogram, 6 months - 1 year after their baseline scan to assess whether baseline fibrosis activity is associated with subsequent deterioration in cardiac and valvular function.

Diagnostic Test: 68Ga-FAPI and 18F-AlF-FAPI PET-MR

Interventions

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

Hybrid Cardiac PET-MR with 68Ga-FAPI and 18F-AlF-FAPI radiotracer

Aortic stenosis; Carcinoid syndrome; Chemotherapy-induced cardiotoxicity

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cohort 1: 70 patients with aortic stenosis with 10 matched healthy volunteers Cohort 2: 60 patients with Chemotherapy-induced cardiotoxicity and 10 healthy volunteers Cohort 3: 30 patients with carcinoid syndrome

You may qualify if:

• Cohort 1(Aortic stenosis):
• Male or female above the age of 50 years old
• Provision of informed consent prior to any study specific procedures
• patients with symptomatic severe aortic stenosis (peak velocity \>4.0 m/s)
• patients with moderate aortic stenosis (peak velocity 3.0-4.0 m/s)
• patients with mild aortic stenosis (peak velocity 2.6-2.9 m/s)
• patients with aortic sclerosis (tri-leaflet thickened aortic valve with no obstruction of ventricular outflow)
• 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.
• patients over the age of 35 years (male or females) without evidence of fibrosis on their 1-year scan after anthracycline treatment.
• 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):
• patients with carcinoid syndrome (with or without cardiac involvement), over the age of 35 years, diagnosed as per consensus guidelines

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Edinburgh: lead

Study Sites (1)

University of Edinburgh

Edinburgh, Scotland, NE7 7EY, United Kingdom

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis; Serotonin Syndrome

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Study Officials

• Marc Dweck, MBBS PhD

  University of Edinburgh

  STUDY CHAIR

Central Study Contacts

Krithika Loganath, MBBS

CONTACT

07774365798; kloganat@ed.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2023
• First Posted: March 6, 2023
• Study Start: November 10, 2022
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: January 9, 2026

Record last verified: 2026-01

Locations

GB (1)