NCT05269446

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 8, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

July 8, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2024

Completed
Last Updated

November 12, 2024

Status Verified

November 1, 2024

Enrollment Period

1.9 years

First QC Date

January 5, 2022

Last Update Submit

November 10, 2024

Conditions

Myocardial Infarction

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

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

    Throughout the 1 year follow-up

Study Arms (3)

STEMI patients

STEMI: patients diagnosed with ST-segment elevation myocardial infarction

Procedure: percutaneous coronary intervention (PCI)Device: total body PET/CT scanProcedure: Coronary Angiography (CAG)Drug: TSPO injection

SA or NSTEMI patients

SA: patients diagnosed with stable angina

Procedure: percutaneous coronary intervention (PCI)Device: total body PET/CT scanProcedure: Coronary Angiography (CAG)Drug: TSPO injection

Healthy subjects

Patients with suspected coronary artery disease, but coronary angiography (CAG) indicates no obvious coronary stenosis

Device: total body PET/CT scanProcedure: Coronary Angiography (CAG)Drug: TSPO injection

Interventions

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

SA or NSTEMI patientsSTEMI patients
total body PET/CT scanDEVICE

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

Healthy subjectsSA or NSTEMI patientsSTEMI patients
Coronary Angiography (CAG)PROCEDURE

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

Healthy subjectsSA or NSTEMI patientsSTEMI patients
TSPO injectionDRUG

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 subjectsSA or NSTEMI patientsSTEMI patients

Eligibility Criteria

Age18 Years - 75 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailshalf male and half female
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji Hospital

Shanghai, 200127, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be collected at D7 and D180 after enrolment

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2022

First Posted

March 8, 2022

Study Start

July 8, 2022

Primary Completion

May 31, 2024

Study Completion

November 10, 2024

Last Updated

November 12, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)