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

Sponsor
University of Brawijaya
Study ID
NCT07604103
Phase
PHASE3
Status
Recruiting
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Conditions

  • Acute Coronary Syndromes (ACS)
  • COPD (Chronic Obstructive Pulmonary Disease)
  • Pneumonia

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
May 22, 2026
Start date
Jan 1, 2026
Status verified
May 2026
Primary completion
Aug 30, 2026
Completion
Oct 10, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Active Comparator: influenza tetravaccine
    influenza tetravaccine 1 dose for each randomized sample
  • Placebo Comparator: Placebo Group
    Placebo group receive 1 dose shot placebo as comparison of the interventional group

Primary Outcome Measure

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

Central Contacts

  • Martha FA Tatodi, MD
    +62895633927741
    [email protected]
  • Rizky Tania Fadillah, MD
    +6281335808012

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