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NCT Number: NCT05519735

Lymphatic Organs and Myocardium After 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.

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinikum Würzburg Mitte, Medizinische Klinik, Würzburg, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multimodality Imaging

Diagnostic Test

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Correlation of quantitative parameters (SUV) with peripheral lymphocytes

    Time frame: 12 months

    SUV of organs of interest are correlated to the phenotype of peripheral lymphocytes in the peripheral blood after myocardial infarction.

  2. Time course of SUV after myocardial infarction

    Time frame: 12 months

    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.

  3. Correlation of myocardial damage to SUV

    Time frame: 12 months

    CMR will determine the extend of myocardial damage as necrotic volume, volume of MVO and myocardial edema. These findings will be correlated to SUV.

  4. Correlation of SUV with the clincial course

    Time frame: 12 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Rudolf Werner, MD

CONTACT

[email protected]

+4993120135906

Theresa Reiter, MD

CONTACT

[email protected]

+4993120139944

Sponsors and collaborators

Lead sponsor

Wuerzburg University Hospital

Other

Registry information

Official study title

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

Acronym: LOMI

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Aug 29, 2022
Registry last updated
May 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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