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.
• 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.