Renji Hospital
Shanghai, 200127, China
NCT Number: NCT05269446
The study will use 18F-PBR06/uExplorer to study the activation of macrophages and systemic perfusion in patients with ST-segment elevation myocardial infarction (STEMI) or stable angina (SA). Participants will receive the total-body PET/CT scan on the seventh day (Day 7, D7) and D180 of enrolment.
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Notify Me18 year–75 year
All sexes
Observational
Shanghai, 200127, China
The aim of our study is to explore the activation of macrophages in patients with ST-segment elevation myocardial infarction (STEMI) or stable angina (SA) using the 18 kDa translocator protein (TSPO) radioligand 18F N-fluoroacetyl-N-(2,5-dimethoxybenzyl)-2-phenoxyaniline (18F-PBR06) in combination with the world's first commercially available total-body PET/CT (uExplorer). The investigators expect to enroll 10 patients diagnosed with STEMI and 10 patients with SA who receive coronary angiography (CAG) and the percutaneous coronary intervention (PCI), and 5-10 healthy individuals diagnosed with SA but presenting negative CAG at Renji Hospital, Shanghai. The activation of macrophages (TSPO uptake) and blood perfusion in different organs will be studied using 18F-PBR06/uExplorer.
With written consent from eligible participants, the investigators will review past medical records and document the medical history for each participant. Patients will undergo PCI on the day of enrolment (12 hours within the symptom onset for STEMI patients). Screen procedures will be performed at the seventh day of enrolment (Day 7, D7) and Day 180 (D180). Participants will receive one dose of the non-therapeutic administration of the radioactive TSPO tracer 18F-PBR06 and receive a whole-body scan by uExplorer. TSPO uptake and blood flow in the heart, kidney, liver, brain, and lung will be recorded. All participants will be followed for 1 year after enrolment. Blood samples will be collected and echocardiography will be performed at D7 and D180. Major adverse cardiovascular events (MACE) will be recorded throughout the follow-up.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A family of minimally invasive procedures used to open clogged coronary arteries and restore blood flow. This is also a standard treatment for patients diagnosed with STEMI or SA
all participants will receive a total-body PET/CT scan (uExplorer) after enrolment
A procedure that uses X-ray imaging to visualize coronary arteries.
Participants will receive one dose of the non-therapeutic administration of the radioactive TSPO tracer 18F-PBR06 before a whole-body scan by uExplorer
Time frame: Day 7 and Day 180 after enrolment
TSPO uptake is assessed by drawing regions of interest (ROI), and determined as the mean of maximal standard uptake value (SUV max)
Time frame: Day 7 and Day 180 after enrolment
Blood flow value is quantified using a reconstructed model, and determined as ml/g/min
Time frame: Throughout the 1 year follow-up
The rate of patients with major adverse cardiovascular events (MACE) occurring during the follow-up
RenJi Hospital
Other
Total-body 18F-PBR06 PET/CT to Evaluate Systemic Inflammation and Perfusion in STEMI and SA Patients Receiving PCI
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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