Myocardial InfarctionLOMINCT05519735
Lymphatic Organs and Myocardium After Myocardial Infarction
A study testing Multimodality Imaging in people with Myocardial Infarction and Myocardial Injury, run by Wuerzburg University Hospital at 2 sites in Germany.
Trial summary
The adaptive immune response plays an important role in myocardial healing and remodeling after acute myocardial infarction in patients. Therefore, the involved lymphocytes represent a novel target for therapeutic interventions. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Myocardial Infarction, Myocardial Injury, Myocardial Inflammation
- What is being tested?
- Multimodality Imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Apr 2022to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with acute myocardial infarction (STEMI) who were treated with immediate catheterization
- stable clinical course
- male/female, above 18 years old
Who cannot join
- hemodynamic instablity > 48 h after immediate catherization
- known CAD
- known structural heart disease
- multi vessel disease
- NSTEMI
- sarcoidosis
Show all 13Show fewer
- immunosuppressive therapy
- acute inflammatory disease
- no consent obtainable
- contraindiations for CMR
- impaired renal function
- active cardiac implants, ferromagnetic implants
- pregnancy, breast-feeding
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites, 2 recruiting
- Recruiting
Klinikum Würzburg Mitte, Medizinische Klinik
Würzburg, 97070
Willibald Hochholzer, Professor
+49 931 7910
- Recruiting
University Hospital Wuerzburg
Würzburg, 97080
Theresa Reiter, +4993120139944, reiter_t@ukw.de
Rudolf Werner, +4993120135906, werner_r1@ukw.de
About this study
Official title: Multimodal Characterization of Lymphatic Organs and Myocardium in Patients After Acute Myocardial Infarction
The adaptive immune response plays an important role in myocardial healing and remodeling after acute myocardial infarction in patients. Therefore, the involved lymphocytes represent a novel target for therapeutic interventions. However, there are no established blood-derived biomarkers to predict the quantity and quality of the adaptive immune response to cardiac injury. Multimodal imaging of the heart and immunologic organs might provide such information.
Recent retrospective analysis of patients after MI revealed enlarged mediastinal lymph nodes associated with increased CXCR4 radiotracer accumulation, thereby indicating that CXCR4 PET-based lymph node imaging provides a non-invasive quantitative readout of the local adaptive immune response. These considerations are further fuelled by the fact that, within lymph nodes, CXCR4 is expressed almost exclusively on lymphocytes, whereas various other cell types express CXCR4 within the myocardium.
Read more
This leads to the hypothesis that the size of mediastinal lymph nodes and their respective CXCR4 PET signals correlate with the adaptive immune response to cardiac injury and might provide predictive information for functional cardiac decline during follow-up.
This prospective clinical study will use multimodal imaging to monitor chemokine receptor 4 (CXCR4) expression in the lymph nodes, myocardium, spleen, and bone marrow after acute MI. The combination of cardiac magnetic resonance (CMR), echocardiography, and positron emission tomography (PET) along with blood collection for immunophenotyping will allow to determine i) if the size of mediastinal lymph nodes and their respective PET-derived CXCR4 signals at baseline correlate with the adaptive immune response to acute cardiac injury; and ii) if they predict cardiac adverse remodelling during longitudinal follow-up.
- Being tested
- Multimodality Imaging
- Keywords
- CXCR4, CMR, Lymphatic organs, Myocardial Infarction
- Medical subject headings
- Myocardial Infarction, Myocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodality ImagingDiagnostic test
Patients receive CXCR4-targeted PET/CT, CMR and Echo
| Study group | Role | What they receive |
|---|---|---|
| Multimodal imaging | Other | Multimodal imaging approach. This includes a CXCR4 targeted PET/CT ([68Ga]Pentixafor) during the acute hospital stay, and serial CMR and Echo imaging. Receives: Diagnostic Test: Multimodality Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
CXCR4 PET-derived uptake after myocardial infarction
Semi-quantitative assessment of CXCR4-derived radiotracer accumulation in the myocardium, mediastinal lymph nodes, bone marrow and spleen in patients after myocardial infarction. For quantitative analysis, standardized uptake values (SUV) will be calculated in organs of interest.
Measured: 12 months
Secondary outcomes (4)
Correlation of quantitative parameters (SUV) with peripheral lymphocytes
SUV of organs of interest are correlated to the phenotype of peripheral lymphocytes in the peripheral blood after myocardial infarction.
Measured: 12 months
Time course of SUV after myocardial infarction
PET/CT scans for each patient will be allocated to either day 3-4 or day 5-8 after myocardial infarction. SUV of organs of interest will be correlated to time point of imaging.
Measured: 12 months
Correlation of myocardial damage to SUV
CMR will determine the extend of myocardial damage as necrotic volume, volume of MVO and myocardial edema. These findings will be correlated to SUV.
Measured: 12 months
Correlation of SUV with the clincial course
Myocardial function (LVEF) and scar volumes as determined by CMR will be correlated to the intital SUV in order to correlate the clinical outcome to the tracer activity.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start1 Apr 2022
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuerzburg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Theresa Reiter, Wuerzburg University Hospital
- Investigators
- Theresa Reiter, MD, Principal investigator, Wuerzburg University HospitalRudolf Werner, MD, Principal investigator, Wuerzburg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05519735
- Sponsor's protocol ID
- 192/21
- Acronym
- LOMI
- Status last verified
- May 2023
- First submitted
- 22 Aug 2022
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Characterization of Lymphatic Organs and Myocardium in Patients After Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT05519735
- Acronym / sponsor ID
- LOMI / 192/21
- Keywords
- CXCR4, CMR, Lymphatic organs, Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Wuerzburg University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 Aug 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 adaptive immune response plays an important role in myocardial healing and remodeling after acute myocardial infarction in patients. Therefore, the involved lymphocytes represent a novel target for therapeutic interventions. However, there are no established blood-derived biomarkers to predict the quantity and quality of the adaptive immune response to cardiac injury. Multimodal imaging of the heart and immunologic organs might provide such information.
Recent retrospective analysis of patients after MI revealed enlarged mediastinal lymph nodes associated with increased CXCR4 radiotracer accumulation, thereby indicating that CXCR4 PET-based lymph node imaging provides a non-invasive quantitative readout of the local adaptive immune response. These considerations are further fuelled by the fact that, within lymph nodes, CXCR4 is expressed almost exclusively on lymphocytes, whereas various other cell types express CXCR4 within the myocardium.
This leads to the hypothesis that the size of mediastinal lymph nodes and their respective CXCR4 PET signals correlate with the adaptive immune response to cardiac injury and might provide predictive information for functional cardiac decline during follow-up.
This prospective clinical study will use multimodal imaging to monitor chemokine receptor 4 (CXCR4) expression in the lymph nodes, myocardium, spleen, and bone marrow after acute MI. The combination of cardiac magnetic resonance (CMR), echocardiography, and positron emission tomography (PET) along with blood collection for immunophenotyping will allow to determine i) if the size of mediastinal lymph nodes and their respective PET-derived CXCR4 signals at baseline correlate with the adaptive immune response to acute cardiac injury; and ii) if they predict cardiac adverse remodelling during longitudinal follow-up.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multimodal imaging | Other | Diagnostic Test: Multimodality ImagingMultimodal imaging approach. This includes a CXCR4 targeted PET/CT ([68Ga]Pentixafor) during the acute hospital stay, and serial CMR and Echo imaging. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with acute myocardial infarction (STEMI) who were treated with immediate catheterization
- stable clinical course
- male/female, above 18 years old
Key exclusion criteria (13 listed)
- hemodynamic instablity > 48 h after immediate catherization
- known CAD
- known structural heart disease
- multi vessel disease
- NSTEMI
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 |
|---|---|---|
| Multimodality ImagingPatients receive CXCR4-targeted PET/CT, CMR and Echo | Diagnostic test | Multimodal imaging |
Primary outcome
CXCR4 PET-derived uptake after myocardial infarction
Time frame: 12 months
Semi-quantitative assessment of CXCR4-derived radiotracer accumulation in the myocardium, mediastinal lymph nodes, bone marrow and spleen in patients after myocardial infarction. For quantitative analysis, standardized uptake values (SUV) will be calculated in organs of interest.
4 secondary outcomes
Correlation of quantitative parameters (SUV) with peripheral lymphocytes
Time frame: 12 months
Time course of SUV after myocardial infarction
Time frame: 12 months
Correlation of myocardial damage to SUV
Time frame: 12 months
Correlation of SUV with the clincial course
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
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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.
Theresa Reiter, MD principal investigator
Wuerzburg University Hospital
Rudolf Werner, MD principal investigator
Wuerzburg University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodality Imaging in people with Myocardial Infarction and Myocardial Injury, run by Wuerzburg University Hospital at 2 sites in Germany.
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 3 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Theresa Reiter, MD (+4993120139944, reiter_t@ukw.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CXCR4 PET-derived uptake after myocardial infarction (time frame: 12 months). 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 25 May 2023.