Lymphatic Organs and Myocardium After Myocardial Infarction

NCT ID: NCT05519735

Last Updated: 2023-05-25

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Myocardial Infarction Myocardial Injury Myocardial Inflammation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

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.

Group Type OTHER

Multimodality Imaging

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wuerzburg University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Theresa Reiter

Principal Investigator

Responsibility Role 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

Site Status RECRUITING

University Hospital Wuerzburg

Würzburg, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Theresa Reiter, MD

Role: CONTACT

+4993120139944

Rudolf Werner, MD

Role: CONTACT

+4993120135906

Facility Contacts

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Willibald Hochholzer, Professor

Role: primary

Role: backup

+49 931 7910

Theresa Reiter

Role: primary

+4993120139944

Rudolf Werner

Role: backup

+4993120135906

Other Identifiers

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192/21

Identifier Type: -

Identifier Source: org_study_id

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