Lymphatic Organs and Myocardium After Myocardial Infarction

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorWuerzburg University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

patients with acute myocardial infarction (STEMI) who were treated with immediate catheterization

stable clinical course

male/female, above 18 years old

Disqualifiers

hemodynamic instablity > 48 h after immediate catherization

known CAD

known structural heart disease

multi vessel disease

Trial design

Design model

Single group

Treatments tested in this trial

  • Multimodality Imaging

    Diagnostic test

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

Treatment groups

57 Participants
are divided into 1 treatment group
Group A: Multimodal imagingOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
12 months

Secondary outcomes

1

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.

Time frame
12 months
2

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.

Time frame
12 months
3

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.

Time frame
12 months
4

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.

Time frame
12 months

Other outcomes

Sponsors and contacts

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