跳至主要内容
临床试验/NCT05519735
NCT05519735招募中不适用

Multimodal Characterization of Lymphatic Organs and Myocardium in Patients After Acute Myocardial Infarction

Wuerzburg University Hospital4 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2022年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
57
试验地点
4
主要终点
CXCR4 PET-derived uptake after myocardial infarction

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • hemodynamic instablity > 48 h after immediate catherization
  • known CAD
  • known structural heart disease
  • multi vessel disease
  • sarcoidosis
  • immunosuppressive therapy
  • acute inflammatory disease
  • no consent obtainable
  • contraindiations for CMR
  • impaired renal function
  • active cardiac implants, ferromagnetic implants
  • pregnancy, breast-feeding

结局指标

主要结局

CXCR4 PET-derived uptake after myocardial infarction

时间窗: 12 months

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.

次要结局

  • Correlation of myocardial damage to SUV(12 months)
  • Correlation of quantitative parameters (SUV) with peripheral lymphocytes(12 months)
  • Time course of SUV after myocardial infarction(12 months)
  • Correlation of SUV with the clincial course(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Theresa Reiter

Principal Investigator

Wuerzburg University Hospital

研究点 (4)

Loading locations...

相似试验