ST-Elevation Myocardial Infarction (STEMI)PARISNCT06956560
Platelet Derived Growth Factor Receptor ß (PDGFRß) Imaging in Cardiac Fibrosis
An observational study of ST-Elevation Myocardial Infarction (STEMI) and Heart Failure With Preserved Ejection Fraction (HFpEF), run by Uppsala University at 1 site in Sweden.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- ST-Elevation Myocardial Infarction (STEMI), Heart Failure With Preserved Ejection Fraction (HFpEF)
- What is being tested?
- PET/MRI or separate PET/CT and MRI
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jun 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible patients with STEMI high- and low-risk, and HFpEF will be recruited and/or identified from referral sites, by Uppsala University Hospital.
Who may be able to join
- 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.
- Cohort-specific inclusion criteria:
- Cohort 1, STEMI high-risk patients:
- NT-proBNP >500 pg/mL within 48 hrs after PCI
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- 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.
Who cannot join
- 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
- 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.
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- 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.
- Additional exclusion criteria for all participants (cohorts 1,2 and 4):
- History of coronary artery disease or heart failure.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Uppsala University Hospital
Uppsala
Karl-Henrik Grinnemo Professor, MD, PhD, +46186110000, karl-henrik.grinnemo@uu.se
About this study
Official title: Microdosing, Non-randomized, Clinical Trial to Investigate Binding of Positron Emission Tomography Tracer [68ga]Ga-DOTA-Cys-ATH001 Targeting Platelet-derived Growth Factor Receptor Beta (PDGFRß) in Healthy Subject as Compared to Patients With Cardiac Fibrosis.
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.
Read the detailed description
PDGFRß is a biomarker for pericytes which are identified as the progenitor of myofibroblast and fibroblast responsible for extra-cellular matrix proteins deposition in fibrotic heart. The Positron Emission Tomography (PET) tracer [68Ga]Ga-Dodecane tetra acetic acid (DOTA)-Cys-ATH001 is a marker for fibrogenic cells by targeting the surface receptor PDGFRß.
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
- ST-Elevation Myocardial Infarction (STEMI), Heart Failure With Preserved Ejection Fraction (HFpEF)
- Being tested
- PET/MRI or separate PET/CT and MRI
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/MRI or separate PET/CT and MRIRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: PET/MRI or separate PET/CT and MRI | |
| 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. Receives: Radiation: PET/MRI or separate PET/CT and MRI | |
| 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. Receives: Radiation: PET/MRI or separate PET/CT and MRI | |
| 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. Receives: Radiation: PET/MRI or separate PET/CT and MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At PET/MRI baseline, and at PET/MRI at 2-8 months after baseline (cohort 1 and 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start1 Jun 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST-Elevation Myocardial Infarction (STEMI)Studies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karl-Henrik Grinnemo, MD, PhD, Principal investigator, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06956560
- Sponsor's protocol ID
- PARIS
- Acronym
- PARIS
- Status last verified
- Aug 2025
- First submitted
- 25 Apr 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microdosing, Non-randomized, Clinical Trial to Investigate Binding of Positron Emission Tomography Tracer [68ga]Ga-DOTA-Cys-ATH001 Targeting Platelet-derived Growth Factor Receptor Beta (PDGFRß) in Healthy Subject as Compared to Patients With Cardiac Fibrosis.
- ClinicalTrials.gov ID
- NCT06956560
- Acronym / sponsor ID
- PARIS / PARIS
- Conditions
- ST-Elevation Myocardial Infarction (STEMI), Heart Failure With Preserved Ejection Fraction (HFpEF)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 4 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PDGFRß is a biomarker for pericytes which are identified as the progenitor of myofibroblast and fibroblast responsible for extra-cellular matrix proteins deposition in fibrotic heart. The Positron Emission Tomography (PET) tracer [68Ga]Ga-Dodecane tetra acetic acid (DOTA)-Cys-ATH001 is a marker for fibrogenic cells by targeting the surface receptor PDGFRß.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Individuals with high risk of heart failure after STEMI | – | Radiation: PET/MRI or separate PET/CT and MRIIndividuals 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. |
| Individuals with low risk of heart failure after STEMI | – | Radiation: PET/MRI or separate PET/CT and MRIIndividuals 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. |
| Individuals diagnosed with HFpEF and with signs/symptoms of heart failure | – | Radiation: PET/MRI or separate PET/CT and MRIIndividuals 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. |
| Healthy control individuals | – | Radiation: PET/MRI or separate PET/CT and MRIHealthy 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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible patients with STEMI high- and low-risk, and HFpEF will be recruited and/or identified from referral sites, by Uppsala University Hospital.
Key inclusion criteria (22 listed)
- 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
- Post-PCI Thrombolysis In Myocardial Infarction (TIMI) score <3.
Key exclusion criteria (20 listed)
- 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
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET/MRI or separate PET/CT and MRIPET/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. | Radiation | Healthy control individuals, Individuals diagnosed with HFpEF and with signs/symptoms of heart failure, Individuals with high risk of heart failure after STEMI, Individuals with low risk of heart failure after STEMI |
Primary outcome
PET-tracer binding in myocardium
Time frame: At PET/MRI baseline, and at PET/MRI at 2-8 months after baseline (cohort 1 and 2)
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.
PET-tracer binding in the infarct
Time frame: At PET/MRI baseline, and at PET/MRI at 2-8 months after baseline (cohort 1 and 2)
Difference in uptake of [68Ga]Ga-DOTA-Cys-ATH001 in the infarct, as identified by Gd-MRI compared to uptake in healthy myocardium.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karl-Henrik Grinnemo, MD, PhD principal investigator
Uppsala University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ST-Elevation Myocardial Infarction (STEMI) and Heart Failure With Preserved Ejection Fraction (HFpEF), run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karl-Henrik Grinnemo, MD, PhD (+46186110000, karl-henrik.grinnemo@uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PET-tracer binding in myocardium (time frame: At PET/MRI baseline, and at PET/MRI at 2-8 months after baseline (cohort 1 and 2)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.