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
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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 3단계
연락처 및 위치
연구 연락처
- 이름: Martha FA Tatodi, MD
- 전화번호: +62895633927741
- 이메일: 3downdoomdrop@gmail.com
연구 연락처 백업
- 이름: Rizky Tania Fadillah, MD
- 전화번호: +6281335808012
연구 장소
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East Java
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Malang, East Java, 인도네시아, 65111
- 모병
- RSUD Dr. Saiful Anwar
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연락하다:
- Martha FA Tatodi, MD
- 전화번호: +62895633927741
- 이메일: 3downdoomdrop@gmail.com
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연락하다:
- Rizky Tania Fadillah, MD
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: influenza tetravaccine
influenza tetravaccine 1 dose for each randomized sample
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Influenza vaccination for 1 interventional group and comparison of GDF-15, MR proADM, Persepsin before and after vaccination in patient with ACS and Pneumonia
다른 이름들:
The patient will get standard care for pneumonia therapy
patient will get percutaneus coronary intervention
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위약 비교기: Placebo Group
Placebo group receive 1 dose shot placebo as comparison of the interventional group
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The patient will get standard care for pneumonia therapy
patient will get percutaneus coronary intervention
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Levels of Inflammatory Biomarkers (GDF-15, MR proADM, and Presepsin)
기간: At baseline (admission) and up to 30 days post-vaccination follow-up.
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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.
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At baseline (admission) and up to 30 days post-vaccination follow-up.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Changes in Biomarker Levels Post-Vaccination
기간: Measured at 4 weeks post-vaccination.
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To evaluate the changes and modulation of GDF-15, MR proADM, and Presepsin levels following Pneumococcal and Influenza vaccinations compared to baseline levels.
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Measured at 4 weeks post-vaccination.
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 400/259/K.3/102.7/2025
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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