18F-PBR06/Total Body PET Imaging in Patients With STEMI

Total-body 18F-PBR06 PET/CT to Evaluate Systemic Inflammation and Perfusion in STEMI and SA Patients Receiving PCI

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction
• Intervention / Treatment: Procedure: percutaneous coronary intervention (PCI); Device: total body PET/CT scan; Procedure: Coronary Angiography (CAG); Drug: TSPO injection

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 26

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200127
    • Renji Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Patients aged between 18 and 75 years with the diagnosis of STEMI or SA will be eligible for our study.

Description

Inclusion Criteria:

• Aged 18-75 years old
• Diagnosed with STEMI, NSTEMI or suspected SA (ACC/AHA guidelines)
• Half male and half female
• Undergo CAG and PCI treatment if necessary (primary PCI for STEMI patients within12 hours after symptom onset)
• Written informed consents will be offered and signed by all participants

Exclusion Criteria:

• History of myocardial infarction/vascular disease/heart failure/systemic inflammatory diseases before enrolment
• Patients who are pregnant/breastfeeding, or in a plan to have a baby during the year after CAG/PCI
• People under the age of 18 years old
• Inability to lie or maintain posture during the scanning procedure

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
STEMI patients; STEMI: patients diagnosed with ST-segment elevation myocardial infarction	Procedure: percutaneous coronary intervention (PCI); 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; Device: total body PET/CT scan; all participants will receive a total-body PET/CT scan (uExplorer) after enrolment; Procedure: Coronary Angiography (CAG); A procedure that uses X-ray imaging to visualize coronary arteries.; Drug: TSPO injection; Participants will receive one dose of the non-therapeutic administration of the radioactive TSPO tracer 18F-PBR06 before a whole-body scan by uExplorer
Healthy subjects; Patients with suspected coronary artery disease, but coronary angiography (CAG) indicates no obvious coronary stenosis	Device: total body PET/CT scan; all participants will receive a total-body PET/CT scan (uExplorer) after enrolment; Procedure: Coronary Angiography (CAG); A procedure that uses X-ray imaging to visualize coronary arteries.; Drug: TSPO injection; Participants will receive one dose of the non-therapeutic administration of the radioactive TSPO tracer 18F-PBR06 before a whole-body scan by uExplorer
SA or NSTEMI patients; SA: patients diagnosed with stable angina	Procedure: percutaneous coronary intervention (PCI); 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; Device: total body PET/CT scan; all participants will receive a total-body PET/CT scan (uExplorer) after enrolment; Procedure: Coronary Angiography (CAG); A procedure that uses X-ray imaging to visualize coronary arteries.; Drug: TSPO injection; Participants will receive one dose of the non-therapeutic administration of the radioactive TSPO tracer 18F-PBR06 before a whole-body scan by uExplorer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline TSPO uptake (SUV max) at 6 month	TSPO uptake is assessed by drawing regions of interest (ROI), and determined as the mean of maximal standard uptake value (SUV max)	Day 7 and Day 180 after enrolment
Change from baseline Blood flow value (ml/g/min) at 6 month	Blood flow value is quantified using a reconstructed model, and determined as ml/g/min	Day 7 and Day 180 after enrolment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of MACE (%)in patients with STEMI and SA	The rate of patients with major adverse cardiovascular events (MACE) occurring during the follow-up	Throughout the 1 year follow-up

Collaborators and Investigators

• Sponsor: RenJi Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2022
• Primary Completion (Actual): May 31, 2024
• Study Completion (Actual): November 10, 2024

Study Registration Dates

• First Submitted: January 5, 2022
• First Submitted That Met QC Criteria: March 7, 2022
• First Posted (Actual): March 8, 2022

Study Record Updates

• Last Update Posted (Estimated): November 12, 2024
• Last Update Submitted That Met QC Criteria: November 10, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Necrosis; Myocardial Ischemia; Ischemia; Myocardial Infarction; Infarction
• Other Study ID Numbers: STEMI-systemic inflammation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No