Clinical trial NCT05519735: Lymphatic Organs and Myocardium After Myocardial Infarction
Official title: Multimodal Characterization of Lymphatic Organs and Myocardium in Patients After Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myocardial Infarction
Myocardial Injury
Myocardial Inflammation
Keywords: CXCR4
CMR
Lymphatic organs
Myocardial Infarction
Lead sponsor: Wuerzburg University Hospital
Sponsor class: OTHER
First posted: 2022-08-29
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: CXCR4 PET-derived uptake after myocardial infarction
timeFrame: 12 months
Secondary outcomes:
measure: Correlation of quantitative parameters (SUV) with peripheral lymphocytes
timeFrame: 12 months
measure: Time course of SUV after myocardial infarction
timeFrame: 12 months
measure: Correlation of myocardial damage to SUV
timeFrame: 12 months
measure: Correlation of SUV with the clincial course
timeFrame: 12 months
Other outcomes:
Locations:
city: Wuerzburg
country: Germany
facility: University Hospital Wuerzburg
city: Würzburg
country: Germany
facility: Klinikum Würzburg Mitte, Medizinische Klinik
Study officials:
affiliation: Wuerzburg University Hospital
name: Theresa Reiter, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wuerzburg University Hospital
name: Rudolf Werner, MD
role: PRINCIPAL_INVESTIGATOR
References: