Lymphatic Organs and Myocardium After Myocardial Infarction

Myocardial Infarction Clinical Trial

— LOMI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05519735
• Other study ID #: 192/21
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: December 2026

Study information

• Verified date: May 2023
• Source: Wuerzburg University Hospital
• Contact: Theresa Reiter, MD
• Phone: +4993120139944
• Email: reiter_t[@]ukw.de
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 57
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Inflammation
• Myocardial Infarction
• Myocardial Inflammation
• Myocardial Injury
• Myocarditis

Intervention

Diagnostic Test:
• Multimodality Imaging
Patients receive CXCR4-targeted PET/CT, CMR and Echo

Locations

Country	Name	City	State
Germany	University Hospital Wuerzburg	Wuerzburg
Germany	Klinikum Würzburg Mitte, Medizinische Klinik	Würzburg

Sponsors (1)

Lead Sponsor	Collaborator
Wuerzburg University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	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.	12 months