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

NCT07604103 | Recruiting Phase 3

• 1 other identifier: 400/259/K.3/102.7/2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

GDF-15; MR proADM; Persepsin; Acute coronary syndrome; Pneumonia; influenza vaccination

Outcome Measures

Primary Outcomes (1)

• Levels of Inflammatory Biomarkers (GDF-15, MR proADM, and Presepsin)

  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.

Secondary Outcomes (1)

• Changes in Biomarker Levels Post-Vaccination

  Measured at 4 weeks post-vaccination.

Study Arms (2)

influenza tetravaccine

ACTIVE COMPARATOR

influenza tetravaccine 1 dose for each randomized sample

Drug: Vaxigrip; Drug: antibiotic treatments; Procedure: percutaneus coronary intervention

Placebo Group

PLACEBO COMPARATOR

Placebo group receive 1 dose shot placebo as comparison of the interventional group

Drug: antibiotic treatments; Procedure: percutaneus coronary intervention

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

Also known as: MR proADM, Persepsin, GDF-15

influenza tetravaccine

antibiotic treatments DRUG

The patient will get standard care for pneumonia therapy

Placebo Group; influenza tetravaccine

percutaneus coronary intervention PROCEDURE

patient will get percutaneus coronary intervention

Placebo Group; influenza tetravaccine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Brawijaya: lead

Study Sites (1)

RSUD Dr. Saiful Anwar

Malang, East Java, 65111, Indonesia

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome; Pneumonia; Pulmonary Disease, Chronic Obstructive; Influenza, Human

Interventions

vaxigrip; Growth Differentiation Factor 15

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Growth Differentiation Factors; TGF-beta Superfamily Proteins; Proteins; Biological Factors

Central Study Contacts

Martha FA Tatodi, MD

CONTACT

+62895633927741; 3downdoomdrop@gmail.com

Rizky Tania Fadillah, MD

CONTACT

+6281335808012

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr

Study Record Dates

• First Submitted: May 16, 2026
• First Posted: May 22, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): October 10, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

ID (1)