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治験 NCT07155395(対象:ST上昇型心筋梗塞 (STEMI)、糖尿病)は募集準備中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
フィルター基準に一致する試験が1件見つかりました
タイル表示
Inflammatory and Hematological Indices in Diabetic STEMI Patients Undergoing Primary PCI 1,000
治験(臨床試験)の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします!「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT07155395 は 観察研究 臨床試験 で、ST上昇型心筋梗塞 (STEMI)、糖尿病 に関するものです。現在は 募集準備中 で、2025年10月1日 に開始予定です。1,000 名の参加者 の募集が計画されています。この試験は アシュート大学 によって主導され、2027年4月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年9月4日 です。
概要
ST-segment Elevation Myocardial Infarction (STEMI) remains a major cause of mortality despite the adoption of Primary Percutaneous Coronary Intervention (PPCI) as the standard treatment. However, outcomes still vary significantly among patients, especially between diabetic and non-diabetic cohorts.
The research question driving this study is: Can hematologic, inflammatory, and thrombotic indices serve as reliable pr...
もっと見る詳細説明
ST-segment Elevation Myocardial Infarction (STEMI) is a critical form of Acute Coronary Syndrome (ACS), resulting from abrupt plaque rupture and thrombotic coronary occlusion. Despite the widespread application of Primary Percutaneous Coronary Intervention (PPCI), STEMI remains one of the leading causes of mortality. Therefore, early stratification and prediction of outcomes is essential.
Recent evidence highlights ...
もっと見る公式タイトル
Relationship Between Inflammatory and Hematological Indices and Coronary Artery Disease Severity and Outcome Among Diabetic Patients Undergoing Primary Percutaneous Coronary Intervention
疾患名
ST上昇型心筋梗塞 (STEMI)糖尿病刊行物
この臨床試験について発表された科学記事と研究論文:その他の研究識別子
- Markers in Diabetic STEMI
NCT番号
開始日
2025-10
最終更新日
2025-09-04
終了予定日
2027-04
目標参加者数
1,000
試験の種類
観察研究
状況
募集準備中
キーワード
STEMI
Diabetes
No reflow
SYNTAX
Hb/RDW
RDW/PDW
NAR
SIRI
SII
CRP
PPCI
Diabetes
No reflow
SYNTAX
Hb/RDW
RDW/PDW
NAR
SIRI
SII
CRP
PPCI
群(アーム)/介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
Diabetic STEMI Patients Patients presenting with ST-segment elevation myocardial infarction (STEMI) and a confirmed diagnosis of diabetes mellitus, undergoing primary percutaneous coronary intervention (PCI). | 該当なし |
Non-Diabetic STEMI Patients Patients presenting with STEMI and no history or diagnosis of diabetes, undergoing primary PCI. | 該当なし |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Incidence of Major Adverse Cardiovascular Events (MACE) | Composite outcome including heart failure, fatal arrhythmia, death, re-infarction, stroke, and urgent target vessel revascularization. The prognostic value of various biomarkers (Hb/RDW, RDW/PDW, NAR, SII, SIRI) will be assessed in diabetic vs. non-diabetic STEMI patients during admission. | Peri-procedural |
Angiographic outcomes including No Reflow Phenomenon | Assessment of angiographic outcomes following primary percutaneous coronary intervention (PPCI), with a specific focus on the incidence of the no-reflow phenomenon. No-reflow will be defined as inadequate myocardial perfusion in the absence of mechanical obstruction. | At time of Primary PCI (within 24 hours of admission) |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Incidence of Major Adverse Cardiovascular Events (MACE) | Composite outcome including heart failure, fatal arrhythmia, death, re-infarction, stroke, and urgent target vessel revascularization. The prognostic value of various biomarkers (Hb/RDW, RDW/PDW, NAR, SII, SIRI) will be assessed in diabetic vs. non-diabetic STEMI patients over the 6-month follow-up period. | Up to 6 months post-PCI |
参加アシスタント
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
- Patients presenting to Assiut University cardiac catheterization laboratory with ST-segment Elevation Myocardial Infarction (STEMI).
- Managed with primary percutaneous coronary intervention (PPCI).
- Patients not eligible for PPCI.
- Patients who underwent thrombolytic therapy or received anti-thrombotics prior to hospital arrival.
- Prior coronary intervention: history of PCI or CABG.
- Known hematological disorders:
Thalassemia (microcytic anemia, normal iron profile, HbA2 ≥ 3.5% or elevated HbF).
Myelodysplastic syndromes (unexplained cytopenias with ≥10% dysplasia in bone marrow aspirate).
Leukemia (persistent leukocytosis or pancytopenia, blasts ≥20% in peripheral blood).
- Active infection or sepsis at admission (e.g., fever, leukocytosis, elevated CRP <100 mg/L without cardiac cause).
- Known autoimmune or chronic inflammatory diseases (e.g., systemic lupus erythematosus).
- Known or newly diagnosed malignancy.
- End-stage renal disease (eGFR <30 ml/min/1.73 m² or on dialysis).
- Advanced hepatic impairment (Child-Pugh class C; bilirubin >3 mg/dL or ALT/AST >3× upper limit of normal).
- Recent blood transfusion within 3 months.
- Recent use of steroids, chemotherapy, or immunosuppressive drugs.
- Mechanical complications or cardiogenic shock prior to or during STEMI presentation (e.g., papillary muscle rupture, ventricular septal defect, need for intra-aortic balloon pump).
責任者
David Emil Efraim Danial, 主任研究者, Resident Cardiologist, Assiut University
試験中央連絡先
連絡先: David Emil Efraim, +201091620534, [email protected]
位置情報がありません。