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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

16. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

60

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

  • Navn: Rizky Tania Fadillah, MD
  • Telefonnummer: +6281335808012

Studiesteder

  • Indonesia
    • East Java
      • Malang, East Java, Indonesia, 65111
        • Rekruttering
        • RSUD Dr. Saiful Anwar
        • Ta kontakt med:
        • Ta kontakt med:
          • Rizky Tania Fadillah, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Diagnostisk
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: influenza tetravaccine
influenza tetravaccine 1 dose for each randomized sample
Legemiddel: 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
Andre navn:
  • MR proADM
  • Persepsin
  • GDF-15
Legemiddel: antibiotic treatments
The patient will get standard care for pneumonia therapy
Fremgangsmåte: percutaneus coronary intervention
patient will get percutaneus coronary intervention
Placebo komparator: Placebo Group
Placebo group receive 1 dose shot placebo as comparison of the interventional group
Legemiddel: antibiotic treatments
The patient will get standard care for pneumonia therapy
Fremgangsmåte: percutaneus coronary intervention
patient will get percutaneus coronary intervention

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Levels of Inflammatory Biomarkers (GDF-15, MR proADM, and Presepsin)
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Changes in Biomarker Levels Post-Vaccination
Tidsramme: 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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Brawijaya

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. januar 2026

Primær fullføring (Antatt)

30. august 2026

Studiet fullført (Antatt)

10. oktober 2026

Datoer for studieregistrering

Først innsendt

16. mai 2026

Først innsendt som oppfylte QC-kriteriene

16. mai 2026

Først lagt ut (Faktiske)

22. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 400/259/K.3/102.7/2025

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

IPD-planbeskrivelse

Because of the privacy of the data (currently anticipated)

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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