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

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Drug Vaxigrip
  Influenza vaccination for 1 interventional group and comparison of GDF-15, MR proADM, Persepsin before and after vaccination in patient with ACS and Pneumonia
• Drug antibiotic treatments
  The patient will get standard care for pneumonia therapy
• Procedure percutaneus coronary intervention
  patient will get percutaneus coronary intervention

Primary outcome measures

• Levels of Inflammatory Biomarkers (GDF-15, MR proADM, and Presepsin) [Time frame: At baseline (admission) and up to 30 days post-vaccination follow-up.]

Secondary outcome measures (1)

• Changes in Biomarker Levels Post-Vaccination [Time frame: Measured at 4 weeks post-vaccination.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Diagnostic

Study locations

Indonesia · 1 center

• RSUD Dr. Saiful Anwar — Malang

Identifiers

NCT: NCT07604103 · 400/259/K.3/102.7/2025

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗