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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- フェーズ 3
連絡先と場所
研究連絡先
- 名前：Martha FA Tatodi, MD
- 電話番号：+62895633927741
- メール：3downdoomdrop@gmail.com
研究連絡先のバックアップ
- 名前：Rizky Tania Fadillah, MD
- 電話番号：+6281335808012
研究場所
-
-
East Java
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Malang、East Java、インドネシア、65111
- 募集
- RSUD Dr. Saiful Anwar
-
コンタクト：
- Martha FA Tatodi, MD
- 電話番号：+62895633927741
- メール：3downdoomdrop@gmail.com
-
コンタクト：
- Rizky Tania Fadillah, MD
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：influenza tetravaccine
influenza tetravaccine 1 dose for each randomized sample
|
Influenza vaccination for 1 interventional group and comparison of GDF-15, MR proADM, Persepsin before and after vaccination in patient with ACS and Pneumonia
他の名前：
The patient will get standard care for pneumonia therapy
patient will get percutaneus coronary intervention
|
|
プラセボコンパレーター：Placebo Group
Placebo group receive 1 dose shot placebo as comparison of the interventional group
|
The patient will get standard care for pneumonia therapy
patient will get percutaneus coronary intervention
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Levels of Inflammatory Biomarkers (GDF-15, MR proADM, and Presepsin)
時間枠：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.
|
At baseline (admission) and up to 30 days post-vaccination follow-up.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Changes in Biomarker Levels Post-Vaccination
時間枠：Measured at 4 weeks 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.
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 400/259/K.3/102.7/2025
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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