Platelet Derived Growth Factor Receptor ß (PDGFRß) Imaging in Cardiac Fibrosis
NCT ID: NCT06956560
Last Updated: 2025-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
30 participants
OBSERVATIONAL
2025-06-01
2026-12-31
Brief Summary
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Detailed Description
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Four cohorts are examined by Positron Emission Tomography/Magnetic Resonance Imaging (PET/MRI) or separate Positron Emission Tomography/Computed Tomography (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).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Individuals with high risk of heart failure after STEMI
Individuals with high risk of heart failure after STEMI are examined by PET 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) at one week after PCI/stent intervention and at 2-8 months after PCI/stent.
PET/MRI or separate PET/CT and MRI
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.
Individuals with low risk of heart failure after STEMI
Individuals with low risk of heart failure after STEMI are examined by PET 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) at one week after PCI/stent intervention and at 2-8 months after PCI/stent.
PET/MRI or separate PET/CT and MRI
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.
Individuals diagnosed with HFpEF and with signs/symptoms of heart failure
Individuals diagnosed with HFpEF are examined by PET 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) once after inclusion.
PET/MRI or separate PET/CT and MRI
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.
Healthy control individuals
Healthy control individuals are examined by PET 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) once after inclusion.
PET/MRI or separate PET/CT and MRI
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.
Interventions
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PET/MRI or separate PET/CT and MRI
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Cohort 1, STEMI high-risk patients:
* NT-proBNP \>500 pg/mL within 48 hrs after PCI
* Post-PCI Thrombolysis In Myocardial Infarction (TIMI) score \<3.
* No previous history of coronary artery disease or heart failure.
Cohort 2, STEMI low-risk patients
* NT-proBNP \<500 pg/mL within 48 hrs after PCI
* Post-PCI TIMI score 3.
* No previous history of coronary artery disease or heart failure.
Cohort 3 (HFpEF patients)
* Presence of signs and symptoms of HF
* Ejection Fraction ≥50%
* Elevated levels of natriuretic peptides (NT-proBNP≥125pg/mL)
* At least one of the following:
* Relevant structural heart disease (left ventricular hypertrophy or left atrial enlargement)
* Diastolic dysfunction
Cohort 4 (healthy participants)
* Individuals with no history of coronary disease or heart failure.
* Medically healthy participant without abnormal clinically significant medical history, physical findings, vital signs, ECG, and laboratory values at the time of the screening visit, as judged by the Investigator.
Exclusion Criteria
* 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
* History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial or influence the results or the participant's ability to participate in the trial.
* Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the screening visit.
* Any malignancy within the past 12 months before the screening visit, with the exception of successfully treated basal cell carcinoma of the skin or in situ prostate cancer under active surveillance, with no interventions scheduled during the period of trial participation.
* Any active gastrointestinal hemorrhage in the past six months.
* Acute or chronic disabling stroke.
* Aortic aneurysm or aortic dissection.
* Hypertensive crisis.
* Circulatory unstable condition in need for mechanical support.
* Any planned major surgery within the duration of the trial participation.
* Participants who are pregnant, currently breastfeeding, or intend to become pregnant during the course of the trial.
* Poor peripheral venous access, as judged by the Investigator.
* The participant has any laboratory abnormality or condition that, in the Investigator's opinion, could adversely affect the safety of the participant or impair the assessment of trial results.
* The participant is using any prohibited concomitant medications as described in the protocol, at the discretion of the Investigator.
* The Investigator considers the participant unlikely to comply with trial procedures, restrictions, and requirements.
* History of coronary artery disease or heart failure.
40 Years
70 Years
ALL
No
Sponsors
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Uppsala University
OTHER
Responsible Party
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Principal Investigators
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Karl-Henrik Grinnemo, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Uppsala University Hospital
Locations
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Uppsala University Hospital
Uppsala, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PARIS
Identifier Type: -
Identifier Source: org_study_id
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