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Lymphatic Organs and Myocardium After Myocardial Infarction

Multimodal Characterization of Lymphatic Organs and Myocardium in Patients After Acute Myocardial Infarction

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05519735
Acronym
LOMI
Enrollment
57
Registered
2022-08-29
Start date
2022-04-01
Completion date
2026-12-31
Last updated
2023-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction, Myocardial Inflammation, Myocardial Injury

Keywords

CXCR4, CMR, Lymphatic organs, Myocardial Infarction

Brief 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. 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.

Interventions

DIAGNOSTIC_TESTMultimodality Imaging

Patients receive CXCR4-targeted PET/CT, CMR and Echo

Sponsors

Wuerzburg University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* patients with acute myocardial infarction (STEMI) who were treated with immediate catheterization * stable clinical course * male/female, above 18 years old

Exclusion criteria

* hemodynamic instablity \> 48 h after immediate catherization * known CAD * known structural heart disease * multi vessel disease * NSTEMI * sarcoidosis * immunosuppressive therapy * acute inflammatory disease * no consent obtainable * contraindiations for CMR * impaired renal function * active cardiac implants, ferromagnetic implants * pregnancy, breast-feeding

Design outcomes

Primary

MeasureTime frameDescription
CXCR4 PET-derived uptake after myocardial infarction12 monthsSemi-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.

Secondary

MeasureTime frameDescription
Correlation of quantitative parameters (SUV) with peripheral lymphocytes12 monthsSUV of organs of interest are correlated to the phenotype of peripheral lymphocytes in the peripheral blood after myocardial infarction.
Time course of SUV after myocardial infarction12 monthsPET/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.
Correlation of myocardial damage to SUV12 monthsCMR will determine the extend of myocardial damage as necrotic volume, volume of MVO and myocardial edema. These findings will be correlated to SUV.
Correlation of SUV with the clincial course12 monthsMyocardial 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.

Countries

Germany

Contacts

Primary ContactTheresa Reiter, MD
reiter_t@ukw.de+4993120139944
Backup ContactRudolf Werner, MD
werner_r1@ukw.de+4993120135906

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026