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New treatment option for Acute Coronary Syndromes (ACS)
Official 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
ClinicalTrials.gov ID: NCT07604103
What this study is testing
What is Vaxigrip?
Vaxigrip is an investigational medicine, being studied as a potential treatment for acute coronary syndromes (acs).
Also referred to as MR proADM, Persepsin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join 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 likely can't join 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Malang, East Java, Indonesia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Malang, East Java, Indonesia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.