NCT07604103RecruitingPhase 3
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
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
Source: ClinicalTrials.gov · Last updated 22 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 16 May 2026
- Start date
- 1 Jan 2026
- Primary completion date
- 30 Aug 2026
- Lead sponsor
- University of Brawijaya
- Diseases
- Coronary artery disease, COPD
- NCT number
- NCT07604103
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 60
- From 1 Jan 2026 to the primary completion date, 30 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with malignancies (cancer), systemic autoimmune diseases, or those currently on long-term immunosuppressant therapy.
Other illness
- Presence of absolute contraindications to pneumococcal and influenza vaccination (history of anaphylactic reactions to vaccine components).
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| RSUD Dr. Saiful Anwar Coordinator of this site? Confirm its status | Malang | Indonesia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.