Lymphatic Organs and Myocardium After Myocardial Infarction
NCT ID: NCT05519735
Last Updated: 2023-05-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
57 participants
INTERVENTIONAL
2022-04-01
2026-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Multimodal imaging
Multimodal imaging approach. This includes a CXCR4 targeted PET/CT (\[68Ga\]Pentixafor) during the acute hospital stay, and serial CMR and Echo imaging.
Multimodality Imaging
Patients receive CXCR4-targeted PET/CT, CMR and Echo
Interventions
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Multimodality Imaging
Patients receive CXCR4-targeted PET/CT, CMR and Echo
Eligibility Criteria
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Inclusion Criteria
* stable clinical course
* male/female, above 18 years old
Exclusion Criteria
* 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
18 Years
90 Years
ALL
No
Sponsors
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Wuerzburg University Hospital
OTHER
Responsible Party
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Theresa Reiter
Principal Investigator
Principal Investigators
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Theresa Reiter, MD
Role: PRINCIPAL_INVESTIGATOR
Wuerzburg University Hospital
Rudolf Werner, MD
Role: PRINCIPAL_INVESTIGATOR
Wuerzburg University Hospital
Locations
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Klinikum Würzburg Mitte, Medizinische Klinik
Würzburg, , Germany
University Hospital Wuerzburg
Würzburg, , Germany
Countries
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Central Contacts
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Facility Contacts
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Willibald Hochholzer, Professor
Role: primary
Role: backup
Other Identifiers
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192/21
Identifier Type: -
Identifier Source: org_study_id
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