Platelet Derived Growth Factor Receptor ß (PDGFRß) Imaging in Cardiac Fibrosis

ConditionsST-Elevation Myocardial Infarction (STEMI)Heart Failure With Preserved Ejection Fraction (HFpEF)

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age40-70

SponsorUppsala University

About this trial

An observational, cross-sectional, longitudinal, microdosing Position Emission Tomography (PET) imaging study to investigate platelet derived growth factor receptor beta (PDGFRß) expression in the heart of patients with high or low risk of heart failure after a ST-Elevation Myocardial Infarction (STEMI) after a percutaneous coronary intervention (PCI) with a stent procedure, as well as in patients with heart failure with preserved ejection fraction (HFpEF) and healthy individuals.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Willing and able to give written informed consent for participation in the trial and able to comply with all trial procedures and requirements.

Male or female participant aged 40 to 70 years, inclusive, at the screening visit.

Women of childbearing potential must practice abstinence from heterosexual intercourse or must agree to use a highly effective method of contraception.

NT-proBNP >500 pg/mL within 48 hrs after PCI

Disqualifiers

Any contraindication for MRI according to a standard checklist

Having worked as a metal worker or welder.

Contraindication for gadolinium-based contrast agents such as risk of nephrogenic systemic fibrosis (NSF) or allergy to gadolinium.

Kidney dysfunction measured as estimated Glomerular filtration rate (eGFR)<30 mL/min/1.73m2

Trial population

Eligible patients with STEMI high- and low-risk, and HFpEF will be recruited and/or identified from referral sites, by Uppsala University Hospital.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

PET/MRI or separate PET/CT and MRI
Radiation
PET/MRI or separate PET/CT and MRI using the following imaging protocol: 15O-H20 (myocardial perfusion, up to 10 min dynamic PET scan), \[68Ga\]Ga-DOTA-Cys-ATH001 (PDGFRß PET, up to 60 min dynamic + static full body PET scans), and Gd-MRI (extracellular volume in infarct, around 10 min MRI scan). Cohort 1 and 2 are examined twice, first one week after PCI/stent and then a second examination 2 to 8 months after the first. Cohorts 3, and 4 are examined once.

Treatment groups

30 Participants

are divided into 4 treatment groups

Group A: Individuals with high risk of heart failure after STEMI1 intervention

Group B: Individuals with low risk of heart failure after STEMI1 intervention

Group C: Individuals diagnosed with HFpEF and with signs/symptoms of heart failure1 intervention

Group D: Healthy control individuals1 intervention

Trial outcomes

Primary outcomes

PET-tracer binding in myocardium

Difference in \[68Ga\]Ga-DOTA-Cys-ATH001 Standardized Uptake Value (SUV)mean / SUVmax / SUVtot in the whole myocardium of healthy subjects compared with STEMI high-risk and low-risk patients, and HFpEF patients.

Time frame

At PET/MRI baseline, and at PET/MRI at 2-8 months after baseline (cohort 1 and 2)

PET-tracer binding in the infarct

Difference in uptake of \[68Ga\]Ga-DOTA-Cys-ATH001 in the infarct, as identified by Gd-MRI compared to uptake in healthy myocardium.

Time frame

At PET/MRI baseline, and at PET/MRI at 2-8 months after baseline (cohort 1 and 2)

Sponsors and contacts

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Uppsala University

Lead sponsor

Source ClinicalTrials.gov

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