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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:
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.
This study focuses on the complex interplay between cardiovascular health and respiratory complications. Acute Coronary Syndrome (ACS) often occurs alongside respiratory conditions like Pneumonia and Chronic Obstructive Pulmonary Disease (COPD), a combination that significantly increases clinical complexity and patient risk. The presence of these comorbidities often triggers a systemic inflammatory response that can be difficult to monitor using standard clinical tools alone.
To better understand this inflammatory landscape, this research evaluates five specific biomarkers:Proteins often associated with heart stress and the body's response to severe infection or inflammation and highly specific markers used to detect and monitor the severity of sepsis and bacterial infections.
A unique aspect of this research is the consideration of Influenza vaccinations. Vaccinations are standard preventative measures for patients with chronic lung and heart diseases, but their influence on the specific biological markers of inflammation during an acute cardiac event remains an area of active investigation.
By measuring these levels, the study seeks to determine if these biomarkers can provide a more "detailed picture" of a patient's condition than traditional methods. This could potentially help clinicians better predict disease progression and understand how prior immunizations might modulate the inflammatory process in patients facing the triple challenge of ACS, pneumonia, and COPD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| influenza tetravaccine | Active Comparator | influenza tetravaccine 1 dose for each randomized sample |
|
| Placebo Group | Placebo Comparator | Placebo group receive 1 dose shot placebo as comparison of the interventional group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Biomarker Levels Post-Vaccination | To evaluate the changes and modulation of GDF-15, MR proADM, and Presepsin levels following Pneumococcal and Influenza vaccinations compared to baseline levels. | Measured at 4 weeks post-vaccination. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martha FA Tatodi, MD | Contact | +62895633927741 | 3downdoomdrop@gmail.com | |
| Rizky Tania Fadillah, MD | Contact | +6281335808012 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RSUD Dr. Saiful Anwar | Recruiting | Malang | East Java | 65111 | Indonesia |
Because of the privacy of the data (currently anticipated)
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|
| antibiotic treatments | Drug | The patient will get standard care for pneumonia therapy |
|
| percutaneus coronary intervention | Procedure | patient will get percutaneus coronary intervention |
|
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D011014 | Pneumonia |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| C478242 | vaxigrip |
| D055436 | Growth Differentiation Factor 15 |
| ID | Term |
|---|---|
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D055412 | Growth Differentiation Factors |
| D055411 | TGF-beta Superfamily Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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