NCT07877324 Vascular Inflammation in Atherosclerosis - Whole Body Molecular PET/CT Imaging Using Folate Receptor β
| NCT ID | NCT07877324 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Turku University Hospital |
| Condition | Atheroscleroses |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2026-10-01 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2026-10-01 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study investigates inflammation in the blood vessels of people with coronary artery disease (CAD) or a recent myocardial infarction. Inflammation plays an important role in the development and progression of atherosclerosis, but there is currently no established clinical imaging method for detecting inflammation in atherosclerotic plaques throughout the body. The study uses a new PET imaging tracer called 18F-AlF-NOTA-Folate. The tracer is designed to bind to folate receptor beta (FR-β), a marker found on activated macrophages, which are immune cells involved in inflammation. The aim is to determine whether PET imaging with this tracer can detect and measure inflammation in atherosclerotic plaques. Approximately 90 patients will participate. One group will include patients with suspected or stable coronary artery disease who are undergoing coronary CT angiography and PET imaging as part of their clinical assessment. A second, smaller group will include patients who have recently had a myocardial infarction. Participants will undergo PET and CT imaging and provide blood samples. The imaging will examine the coronary arteries and other major arteries, including the carotid arteries, aorta and iliac arteries. The study will also investigate blood flow in the heart and other organs and examine the relationship between vascular inflammation, atherosclerotic plaque characteristics and markers of inflammation in the blood. The study is not testing a treatment for coronary artery disease. The folate tracer is administered only for imaging purposes. Participants will be followed through hospital and registry records for up to five years to investigate whether imaging findings are associated with later cardiovascular events. The study may provide new information about how inflammation is distributed in atherosclerosis and whether FR-β-targeted PET imaging could be useful for detecting and studying vascular inflammation in patients with cardiovascular disease.
Eligibility Criteria
Inclusion Criteria: Group A: \- Patients aged 50-80 years with suspected coronary artery disease who have undergone coronary CT angiography and are referred for cardiac 15O-water PET perfusion imaging based on suspected obstructive coronary artery disease. Group B: \- Patients aged 50-80 years with a recent myocardial infarction. For both group A and B: \- Written informed consent. Exclusion Criteria: * unstable angina symptoms * previous myocardial infarction (Group A) * previous coronary artery bypass grafting or previous percutaneous coronary intervention * severe pulmonary disease * severe symptomatic asthma * severe valvular disease * uncontrolled hypertension (\>180/110 mmHg) * severe hypotension (systolic blood pressure \<100 mmHg) * severe renal failure * pregnancy * age \<50 or \>80 years * second- or third-degree atrioventricular block or sick sinus syndrome without a pacemaker * allergy to X-ray contrast agents * known inflammatory disease, including rheumatic or autoimmune disease, sarcoidosis, or myocarditis * known infection * use of anti-inflammatory medication or folate antagonists such as corticosteroids or methotrexate; known cancer.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07877324 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 80 Years, studying Atheroscleroses. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07877324 currently recruiting?
Yes, NCT07877324 is actively recruiting participants. Contact the research team at antsaras@utu.fi for enrollment information.
Where is the NCT07877324 trial being conducted?
This trial is being conducted at Turku, Finland.
Who is sponsoring the NCT07877324 clinical trial?
NCT07877324 is sponsored by Turku University Hospital. The trial plans to enroll 90 participants.