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.

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Observational
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 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
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 70
Healthy Volunteers: f
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• 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

• 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.

Locations
Other Locations
Sweden
Uppsala University Hospital
RECRUITING
Uppsala
Contact Information
Primary
Karl-Henrik Grinnemo, MD, PhD
karl-henrik.grinnemo@uu.se
+46186110000
Time Frame
Start Date: 2025-06-01
Estimated Completion Date: 2026-12
Participants
Target number of participants: 30
Treatments
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.
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.
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.
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.
Sponsors
Leads: Uppsala University

This content was sourced from clinicaltrials.gov