Myocardial InfarctionNCT05269446
18F-PBR06/Total Body PET Imaging in Patients With STEMI
An observational study of Myocardial Infarction, run by RenJi Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- percutaneous coronary intervention (PCI), total body PET/CT scan and Coronary Angiography (CAG)
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- How many people
- 26 participants
- Where
- 1 siteChina
- Study dates
- 8 Jul 2022to 10 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients aged between 18 and 75 years with the diagnosis of STEMI or SA will be eligible for our study.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Myocardial Infarction
- Being tested
- percutaneous coronary intervention (PCI), total body PET/CT scan, Coronary Angiography (CAG), TSPO injection
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous coronary intervention (PCI)Procedure or surgery
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 scanDevice
all participants will receive a total-body PET/CT scan (uExplorer) after enrolment
Coronary Angiography (CAG)Procedure or surgery
A procedure that uses X-ray imaging to visualize coronary arteries.
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
| Study group | Role | What they receive |
|---|---|---|
| STEMI patients | STEMI: patients diagnosed with ST-segment elevation myocardial infarction Receives: Procedure: percutaneous coronary intervention (PCI); Device: total body PET/CT scan; Procedure: Coronary Angiography (CAG); Drug: TSPO injection | |
| SA or NSTEMI patients | SA: patients diagnosed with stable angina Receives: Procedure: percutaneous coronary intervention (PCI); Device: total body PET/CT scan; Procedure: Coronary Angiography (CAG); Drug: TSPO injection | |
| Healthy subjects | Patients with suspected coronary artery disease, but coronary angiography (CAG) indicates no obvious coronary stenosis Receives: Device: total body PET/CT scan; Procedure: Coronary Angiography (CAG); Drug: TSPO injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: Day 7 and Day 180 after enrolment
Secondary outcomes (1)
Incidence of MACE (%)in patients with STEMI and SA
The rate of patients with major adverse cardiovascular events (MACE) occurring during the follow-up
Measured: Throughout the 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start8 Jul 2022
- Primary completion31 May 2024
- Study completion10 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05269446
- Sponsor's protocol ID
- STEMI-systemic inflammation
- Status last verified
- Nov 2024
- First submitted
- 5 Jan 2022
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total-body 18F-PBR06 PET/CT to Evaluate Systemic Inflammation and Perfusion in STEMI and SA Patients Receiving PCI
- ClinicalTrials.gov ID
- NCT05269446
- Acronym / sponsor ID
- STEMI-systemic inflammation
- Conditions
- Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 8 Jul 2022 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 10 Nov 2024 (actual)
- First posted
- 8 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| STEMI patients | – | Procedure: percutaneous coronary intervention (PCI), Device: total body PET/CT scan, Procedure: Coronary Angiography (CAG), Drug: TSPO injectionSTEMI: patients diagnosed with ST-segment elevation myocardial infarction |
| SA or NSTEMI patients | – | Procedure: percutaneous coronary intervention (PCI), Device: total body PET/CT scan, Procedure: Coronary Angiography (CAG), Drug: TSPO injectionSA: patients diagnosed with stable angina |
| Healthy subjects | – | Device: total body PET/CT scan, Procedure: Coronary Angiography (CAG), Drug: TSPO injectionPatients with suspected coronary artery disease, but coronary angiography (CAG) indicates no obvious coronary stenosis |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged between 18 and 75 years with the diagnosis of STEMI or SA will be eligible for our study.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | SA or NSTEMI patients, STEMI patients |
| total body PET/CT scanall participants will receive a total-body PET/CT scan (uExplorer) after enrolment | Device | Healthy subjects, SA or NSTEMI patients, STEMI patients |
| Coronary Angiography (CAG)A procedure that uses X-ray imaging to visualize coronary arteries. | Procedure or surgery | Healthy subjects, SA or NSTEMI patients, STEMI patients |
| TSPO injectionParticipants will receive one dose of the non-therapeutic administration of the radioactive TSPO tracer 18F-PBR06 before a whole-body scan by uExplorer | Drug | Healthy subjects, SA or NSTEMI patients, STEMI patients |
Primary outcome
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)
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
1 secondary outcome
Incidence of MACE (%)in patients with STEMI and SA
Time frame: Throughout the 1 year follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline TSPO uptake (SUV max) at 6 month (time frame: Day 7 and Day 180 after enrolment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.