Acute Coronary Syndromes (ACS)Phase 3NCT07604103
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
A Phase 3 study testing Vaxigrip, antibiotic treatments and percutaneus coronary intervention in people with Acute Coronary Syndromes (ACS) and Pneumonia, run by University of Brawijaya at 1 site in Indonesia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Coronary Syndromes (ACS), Pneumonia, COPD (Chronic Obstructive Pulmonary Disease)
- What is being tested?
- Vaxigrip, antibiotic treatments and percutaneus coronary intervention
- Type of treatment
- Vaccines, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jan 2026to 10 Oct 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rizky Tania Fadillah, MD contact
Indonesia1 site, 1 recruiting
- Recruiting
RSUD Dr. Saiful Anwar
Malang, East Java, 65111
Martha FA Tatodi, MD, +62895633927741, 3downdoomdrop@gmail.com
Rizky Tania Fadillah, MD
About this study
Official title: 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
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:
Read more
- 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.
Read the detailed description
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.
- Being tested
- Vaxigrip, antibiotic treatments, percutaneus coronary intervention
- Keywords
- GDF-15, MR proADM, Persepsin, Acute coronary syndrome, Pneumonia, influenza vaccination
- Medical subject headings
- Acute Coronary Syndrome, Pneumonia, Pulmonary Disease, Chronic Obstructive, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VaxigripDrug
Also called MR proADM, Persepsin, GDF-15
Influenza vaccination for 1 interventional group and comparison of GDF-15, MR proADM, Persepsin before and after vaccination in patient with ACS and Pneumonia
antibiotic treatmentsDrug
The patient will get standard care for pneumonia therapy
percutaneus coronary interventionProcedure or surgery
patient will get percutaneus coronary intervention
| Study group | Role | What they receive |
|---|---|---|
| influenza tetravaccine | Active comparator | influenza tetravaccine 1 dose for each randomized sample Receives: Drug: Vaxigrip; Drug: antibiotic treatments; Procedure: percutaneus coronary intervention |
| Placebo Group | Placebo comparator | Placebo group receive 1 dose shot placebo as comparison of the interventional group Receives: Drug: antibiotic treatments; Procedure: percutaneus coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline (admission) and up to 30 days post-vaccination follow-up.
Secondary outcomes (1)
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: Measured at 4 weeks post-vaccination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start1 Jan 2026
- Primary completion30 Aug 2026 (estimated)
- Study completion10 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary Syndromes (ACS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Brawijaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martha Fitri Alextina Tatodi, University of Brawijaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07604103
- Sponsor's protocol ID
- 400/259/K.3/102.7/2025
- Status last verified
- May 2026
- First submitted
- 16 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Because of the privacy of the data (currently anticipated)
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07604103
- Acronym / sponsor ID
- 400/259/K.3/102.7/2025
- Keywords
- GDF-15, MR proADM, Persepsin, Acute coronary syndrome, Pneumonia, influenza vaccination
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of BrawijayaUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 10 Oct 2026 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| influenza tetravaccine | Active comparator | Drug: Vaxigrip, Drug: antibiotic treatments, Procedure: percutaneus coronary interventioninfluenza tetravaccine 1 dose for each randomized sample |
| Placebo Group | Placebo comparator | Drug: antibiotic treatments, Procedure: percutaneus coronary interventionPlacebo group receive 1 dose shot placebo as comparison of the interventional group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VaxigripAlso: MR proADM, Persepsin, GDF-15Influenza vaccination for 1 interventional group and comparison of GDF-15, MR proADM, Persepsin before and after vaccination in patient with ACS and Pneumonia | Drug | influenza tetravaccine |
| antibiotic treatmentsThe patient will get standard care for pneumonia therapy | Drug | Placebo Group, influenza tetravaccine |
| percutaneus coronary interventionpatient will get percutaneus coronary intervention | Procedure or surgery | Placebo Group, influenza tetravaccine |
Primary outcome
Levels of Inflammatory Biomarkers (GDF-15, MR proADM, and Presepsin)
Time frame: At baseline (admission) and up to 30 days post-vaccination follow-up.
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.
1 secondary outcome
Changes in Biomarker Levels Post-Vaccination
Time frame: Measured at 4 weeks post-vaccination.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Undecided. Because of the privacy of the data (currently anticipated)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rizky Tania Fadillah, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vaxigrip, antibiotic treatments and percutaneus coronary intervention in people with Acute Coronary Syndromes (ACS) and Pneumonia, run by University of Brawijaya at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martha FA Tatodi, MD (+62895633927741, 3downdoomdrop@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of Inflammatory Biomarkers (GDF-15, MR proADM, and Presepsin) (time frame: At baseline (admission) and up to 30 days post-vaccination follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.