Lymphatic Organs and Myocardium After Myocardial Infarction

NCT05519735 | Recruiting

• 1 other identifier: 192/21
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 2

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.

Conditions

Myocardial Infarction; Myocardial Injury; Myocardial Inflammation

Keywords

CXCR4; CMR; Lymphatic organs; Myocardial Infarction

Outcome Measures

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.

  12 months

Secondary Outcomes (4)

• Correlation of quantitative parameters (SUV) with peripheral lymphocytes

  12 months

• Time course of SUV after myocardial infarction

  12 months

• Correlation of myocardial damage to SUV

  12 months

• Correlation of SUV with the clincial course

  12 months

Study Arms (1)

Multimodal imaging

OTHER

Multimodal imaging approach. This includes a CXCR4 targeted PET/CT (\[68Ga\]Pentixafor) during the acute hospital stay, and serial CMR and Echo imaging.

Diagnostic Test: Multimodality Imaging

Interventions

Multimodality Imaging DIAGNOSTIC_TEST

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

Multimodal imaging

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with acute myocardial infarction (STEMI) who were treated with immediate catheterization
• stable clinical course
• male/female, above 18 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Wuerzburg University Hospital: lead

Study Sites (2)

Klinikum Würzburg Mitte, Medizinische Klinik

Würzburg, 97070, Germany

RECRUITING

University Hospital Wuerzburg

Würzburg, 97080, Germany

RECRUITING

MeSH Terms

Conditions

Myocardial Infarction; Myocarditis

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Cardiomyopathies

Study Officials

• Theresa Reiter, MD

  Wuerzburg University Hospital

  PRINCIPAL INVESTIGATOR

• Rudolf Werner, MD

  Wuerzburg University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Theresa Reiter, MD

CONTACT

+4993120139944; reiter_t@ukw.de

Rudolf Werner, MD

CONTACT

+4993120135906; werner_r1@ukw.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 29, 2022
• Study Start: April 1, 2022
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 25, 2023

Record last verified: 2023-05

Locations

DE (2)