Biomarker patterns in ACS patients with pneumonia and COPD after flu vaccination

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional Phase 3 study analyzes relationships between GDF-15, Mid Regional proADM, and Presepsin in adults with ACS and respiratory comorbidities who have received influenza vaccination. It is observational in design but involves measurements alongside standard therapies, including Vaxigrip vaccination, antibiotics, and percutaneous coronary intervention. Researchers will compare biomarker levels with clinical outcomes and vaccination status to see if these markers reflect inflammatory and disease status beyond traditional assessments. The study aims to determine if these biomarkers can provide a more detailed view of patient condition during the overlap of ACS, pneumonia, and COPD. Enrollment focuses on adults under 65 who are active smokers and have demonstrated stabilization after initial therapy.

Why it matters

Who can join: the full rules

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.

Where it's running

• RSUD Dr. Saiful Anwar
  Malang, East Java, Indonesia Recruiting

Study contacts

• Study coordinator: Martha FA Tatodi, MD
• Email: 3downdoomdrop@gmail.com
• Phone: +62895633927741

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.