RecruitingPhase 3NCT07604103

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

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


Sponsor

University of Brawijaya

Enrollment

60 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria5

  • 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 Criteria7

  • 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.

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Interventions

DRUGVaxigrip

Influenza vaccination for 1 interventional group and comparison of GDF-15, MR proADM, Persepsin before and after vaccination in patient with ACS and Pneumonia

DRUGantibiotic treatments

The patient will get standard care for pneumonia therapy

PROCEDUREpercutaneus coronary intervention

patient will get percutaneus coronary intervention


Locations(1)

RSUD Dr. Saiful Anwar

Malang, East Java, Indonesia

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NCT07604103


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