Fibrosis in Chronic and Delayed Myocardial Infarction

ConditionsAortic Stenosis Chemotherapy Induced Systolic Dysfunction Carcinoid Syndrome

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age40-90

SponsorUniversity of Edinburgh

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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.

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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

Treatment groups

180 Participants

are divided into 3 treatment groups

Group A: Aortic stenosis1 intervention

Group B: Chemotherapy-induced cardiotoxicity1 intervention

Group C: Carcinoid syndrome1 intervention

Trial outcomes

Primary outcomes

Fibrosis activity: Standardised uptake values (SUV

SUV

Time frame

1-2 years

Fibrosis activity:Tissue-to-Background Ratio

TBR

Time frame

1-2 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Edinburgh

Lead sponsor

Source ClinicalTrials.gov

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