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Completed

NCT Number: NCT05269446

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

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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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Renji Hospital

Shanghai, 200127, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Percutaneous Coronary Intervention (PCI)

Procedure

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

total body PET/CT scan

Device

all participants will receive a total-body PET/CT scan (uExplorer) after enrolment

Coronary Angiography (CAG)

Procedure

A procedure that uses X-ray imaging to visualize coronary arteries.

TSPO injection

Drug

Participants will receive one dose of the non-therapeutic administration of the radioactive TSPO tracer 18F-PBR06 before a whole-body scan by uExplorer

Primary outcomes

  1. Change from baseline TSPO uptake (SUV max) at 6 month

    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)

  2. Change from baseline Blood flow value (ml/g/min) at 6 month

    Time frame: Day 7 and Day 180 after enrolment

    Blood flow value is quantified using a reconstructed model, and determined as ml/g/min

Secondary outcomes

  1. Incidence of MACE (%)in patients with STEMI and SA

    Time frame: Throughout the 1 year follow-up

    The rate of patients with major adverse cardiovascular events (MACE) occurring during the follow-up

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 8, 2022
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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