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临床试验 NCT07155395 针对ST段抬高型心肌梗死 (STEMI),糖尿病目前尚未招募。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情,或在此提出任何问题。 | ||
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卡片视图
糖尿病ST段抬高型心肌梗死患者行直接PCI的炎症与血液学指标 1,000
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临床试验NCT07155395是一项针对ST段抬高型心肌梗死 (STEMI),糖尿病的观察研究试验,当前状态为尚未招募。试验尚未开始,计划于2025年10月1日开始,预计招募1,000名患者。该研究由艾斯尤特大学主导,计划于2027年4月1日完成。试验数据来源于ClinicalTrials.gov,最后更新时间为2025年9月4日。
简要概括
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...
显示更多详细描述
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 ...
显示更多官方标题
Relationship Between Inflammatory and Hematological Indices and Coronary Artery Disease Severity and Outcome Among Diabetic Patients Undergoing Primary Percutaneous Coronary Intervention
疾病
ST段抬高型心肌梗死 (STEMI)糖尿病出版物
关于此临床试验发表的科学文章和研究论文:其他研究标识符
- Markers in Diabetic STEMI
NCT编号
实际开始日期
2025-10
最近更新发布
2025-09-04
预计完成日期
2027-04
计划入组人数
1,000
研究类型
观察研究
试验状态
尚未招募
关键词
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
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
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). | 不适用 |
Non-Diabetic STEMI Patients Patients presenting with STEMI and no history or diagnosis of diabetes, undergoing primary PCI. | 不适用 |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
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) |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
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 |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
- 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).
研究责任方
David Emil Efraim Danial, 主要研究者, Resident Cardiologist, Assiut University
研究中心联系人
联系人: David Emil Efraim, +201091620534, [email protected]
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