Actively Recruiting
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
Led by University of Brawijaya · Updated on 2026-05-22
60
Participants Needed
1
Research Sites
5 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research investigates the connection between specific biomarkers and health outcomes in patients with Acute Coronary Syndrome (ACS) who also have Pneumonia and Chronic Obstructive Pulmonary Disease (COPD). The study aims to understand how the levels of Growth Differentiation Factor 15 (GDF-15), Mid Regional proAdrenomedullin (MR proADM), and Presepsin relate to inflammation and clinical status, particularly in those who have received Influenza vaccinations. Researchers want to see if these biomarkers can provide more detailed insights into the patients' conditions and the impact of prior immunizations. Participants are randomly assigned to receive either an influenza tetravalent vaccine called Vaxigrip or a placebo injection. Alongside this, they will continue to receive standard pneumonia treatments and may undergo procedures like percutaneous coronary intervention for ACS. The study monitors biomarker levels at hospital admission and for up to 30 days after vaccination to compare changes between groups. This phase 3 trial includes a triple masking design to ensure unbiased results. During the study, participants will have clinical assessments for ACS, pneumonia, and COPD, and provide their influenza vaccination history. Blood samples will be collected to measure the biomarker levels at baseline and 4 weeks post-vaccination. Researchers track changes in these markers to evaluate inflammation and response to vaccination. The total participation involves follow-up visits and biomarker evaluations to analyze how vaccination status affects these inflammatory proteins over time.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult male patients under 65 years old
- History of active smoking
- Confirmed diagnosis of Acute Coronary Syndrome and Pneumonia based on clinical, laboratory, and radiological criteria
- Clinical improvement after standard ACS and Pneumonia therapy in the acute intrahospital phase
- Willingness to undergo all study procedures and sign the Informed Consent form
You will not qualify if you...
- Absolute contraindications to pneumococcal and influenza vaccination (e.g., history of anaphylactic reactions to vaccine components)
- Presence of malignancies, systemic autoimmune diseases, or current long-term immunosuppressant therapy
- End-Stage Renal Disease or severe liver dysfunction affecting biomarker values
- Persistently unstable hemodynamic conditions or unresolved cardiogenic shock during acute care
- Patient death before completing the observation period
- Withdrawal of consent or unilateral resignation during the study
- Lost to follow-up during scheduled outpatient visits or biomarker evaluations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - Up to 1 day for vaccination or placebo administration during hospital stay
Participants receive either an influenza vaccination or a placebo injection and continue their standard care for Acute Coronary Syndrome and Pneumonia, including antibiotic treatments and percutaneous coronary intervention if applicable.
1 baseline visit (in-person) at admission
Duration - Up to 30 days post-vaccination
Participants are monitored for changes in inflammatory biomarker levels up to 30 days post-vaccination or placebo to assess disease progression and the effect of prior immunizations.
Approximately 2 follow-up visits (in-person) within 30 days
Trial Site Locations
Total: 1 location
1
RSUD Dr. Saiful Anwar
Malang, East Java, Indonesia, 65111
Actively Recruiting
Research Team
M
Martha FA Tatodi, MD
R
Rizky Tania Fadillah, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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