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Analysis of Growth Differentiation Factor 15 (GDF-15), Mid Regional proAdrenomedullin (MR proADM), and Persepsin Levels in Patient in Acute Coronary Syndrome Patients With Pneumonia, With or Without Influenza Vaccination

2026年5月16日 更新者:Martha Fitri Alextina Tatodi、University of Brawijaya

Analysis of the Relationship Between Growth Differentiation Factor 15 (GDF-15), Mid Regional proAdrenomedullin (MR proADM), and Persepsin Levels in Patients With Acute Coronary Syndrome With Pneumonia and Chronic Obstructive Pulmonary Disease (COPD) With Influenza Vaccination

The goal of this observational study is to analyze the relationship between various biomarkers (GDF-15, MR proADM, and Presepsin) in patients with Acute Coronary Syndrome (ACS) who also have Pneumonia and Chronic Obstructive Pulmonary Disease (COPD) and have received Influenza vaccinations.

The main questions it aims to answer are:

  • Is there a significant correlation between the levels of these specific biomarkers and the clinical outcomes or inflammatory status of these patients?
  • How does Influenza vaccinations relate to the levels of these biomarkers in the context of ACS with comorbid respiratory conditions? Researchers will compare the levels of these biomarkers across the participant group to see if they can serve as indicators of the patients' health status or the impact of the vaccinations.

Participants will:

- Undergo clinical assessment for Acute Coronary Syndrome, Pneumonia, and COPD. Provide medical history regarding Influenza vaccination status. Provide blood samples for the measurement of GDF-15, MR proADM, and Presepsin levels.

研究概览

详细说明

This study focuses on the complex interplay between cardiovascular health and respiratory complications. Acute Coronary Syndrome (ACS) often occurs alongside respiratory conditions like Pneumonia and Chronic Obstructive Pulmonary Disease (COPD), a combination that significantly increases clinical complexity and patient risk. The presence of these comorbidities often triggers a systemic inflammatory response that can be difficult to monitor using standard clinical tools alone.

To better understand this inflammatory landscape, this research evaluates five specific biomarkers:Proteins often associated with heart stress and the body's response to severe infection or inflammation and highly specific markers used to detect and monitor the severity of sepsis and bacterial infections.

A unique aspect of this research is the consideration of Influenza vaccinations. Vaccinations are standard preventative measures for patients with chronic lung and heart diseases, but their influence on the specific biological markers of inflammation during an acute cardiac event remains an area of active investigation.

By measuring these levels, the study seeks to determine if these biomarkers can provide a more "detailed picture" of a patient's condition than traditional methods. This could potentially help clinicians better predict disease progression and understand how prior immunizations might modulate the inflammatory process in patients facing the triple challenge of ACS, pneumonia, and COPD.

研究类型

介入性

注册 (估计的)

60

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

  • 姓名:Rizky Tania Fadillah, MD
  • 电话号码:+6281335808012

学习地点

    • East Java
      • Malang、East Java、印度尼西亚、65111
        • 招聘中
        • RSUD Dr. Saiful Anwar
        • 接触:
        • 接触:
          • Rizky Tania Fadillah, MD

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Adult male patients (< 65 years old).
  • History of being an active smoker.
  • Confirmed diagnosis of Acute Coronary Syndrome (ACS) and Pneumonia based on clinical, laboratory, and radiological criteria.
  • Demonstrated clinical improvement (stabilization) after receiving standard ACS and Pneumonia therapy in the acute intrahospital phase.
  • Willing to undergo all study procedures and sign the Informed Consent form.

Exclusion Criteria:

  • Presence of absolute contraindications to pneumococcal and influenza vaccination (history of anaphylactic reactions to vaccine components).
  • Patients with malignancies (cancer), systemic autoimmune diseases, or those currently on long-term immunosuppressant therapy.
  • Patients with End-Stage Renal Disease (ESRD) or severe liver dysfunction that could confound inflammatory biomarker values.
  • Patients with persistently unstable hemodynamic conditions or unresolved cardiogenic shock during the acute care phase.
  • Patient death before the observation period (up to post-vaccination) is completed.
  • Patient unilaterally resigns or withdraws consent during the study.
  • Lost to follow-up during scheduled outpatient clinic visits or scheduled follow-up biomarker evaluations.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:诊断
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:三倍

武器和干预

参与者组/臂
干预/治疗
有源比较器:influenza tetravaccine
influenza tetravaccine 1 dose for each randomized sample
Influenza vaccination for 1 interventional group and comparison of GDF-15, MR proADM, Persepsin before and after vaccination in patient with ACS and Pneumonia
其他名称:
  • MR proADM
  • Persepsin
  • GDF-15
The patient will get standard care for pneumonia therapy
patient will get percutaneus coronary intervention
安慰剂比较:Placebo Group
Placebo group receive 1 dose shot placebo as comparison of the interventional group
The patient will get standard care for pneumonia therapy
patient will get percutaneus coronary intervention

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Levels of Inflammatory Biomarkers (GDF-15, MR proADM, and Presepsin)
大体时间:At baseline (admission) and up to 30 days post-vaccination follow-up.
The measurement of serum or plasma concentrations for Growth Differentiation Factor 15, Mid-Regional pro-Adrenomedullin, and Presepsin. This outcome aims to evaluate the systemic inflammatory profile in patients with Acute Coronary Syndrome, Pneumonia, and COPD, and to observe their relationship with vaccination status.
At baseline (admission) and up to 30 days post-vaccination follow-up.

次要结果测量

结果测量
措施说明
大体时间
Changes in Biomarker Levels Post-Vaccination
大体时间:Measured at 4 weeks post-vaccination.
To evaluate the changes and modulation of GDF-15, MR proADM, and Presepsin levels following Pneumococcal and Influenza vaccinations compared to baseline levels.
Measured at 4 weeks post-vaccination.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年1月1日

初级完成 (估计的)

2026年8月30日

研究完成 (估计的)

2026年10月10日

研究注册日期

首次提交

2026年5月16日

首先提交符合 QC 标准的

2026年5月16日

首次发布 (实际的)

2026年5月22日

研究记录更新

最后更新发布 (实际的)

2026年5月22日

上次提交的符合 QC 标准的更新

2026年5月16日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

IPD 计划说明

Because of the privacy of the data (currently anticipated)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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