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

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05269446
• Other study ID #: STEMI-systemic inflammation
• Status: Recruiting
• Start date: July 8, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: RenJi Hospital
• Contact: Zhiguo Zou, MD, PhD
• Phone: +86 13524596108
• Email: zouzhiguo[@]renji.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

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

Locations

Country	Name	City	State
China	Renji Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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