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临床试验/NCT07132489
NCT07132489尚未招募不适用

Validation of Novel Metabolic, Inflammatory, and Hepatic-Renal Biomarkers-HbA1c/C-peptide Ratio, Neutrophil/HDL Ratio, and ALBI Score-for Predicting the No-Reflow Phenomenon After Primary PCI in Patients With STEMI.

Assiut University0 个研究点目标入组 114 人开始时间: 2025年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
114
主要终点
HbA1c/C-peptide ratio predictive accuracy for no-reflow phenomenon

研究概览

简要总结

To evaluate the diagnostic value of the selected emerging biomarkers in predicting the no-reflow phenomenon among patients presenting with STEMI undergoing primary PCI. These biomarkers include:

HbA1c/C-peptide ratio

Albumin-bilirubin (ALBI) score.

Neutrophil/HDL ratio

详细描述

The no-reflow phenomenon is a well-recognized complication following primary percutaneous coronary intervention (PCI) in patients presenting with ST-segment elevation myocardial infarction (STEMI). Despite successful opening of the occluded coronary artery, impaired myocardial perfusion may persist, significantly increasing the risk of adverse cardiovascular outcomes.

Recent research has identified several novel biomarkers that may help predict the risk of no-reflow. These include metabolic, inflammatory, and hepatic-renal markers that reflect the systemic milieu of patients with acute coronary syndromes. Among these emerging biomarkers, the following are of particular interest:

  • HbA1c/C-peptide ratio: Reflects chronic glycemic burden and residual beta-cell function.
  • Neutrophil/HDL ratio: A combined marker of inflammation and lipid-associated atheroprotection.
  • Albumin-bilirubin (ALBI) score: A composite liver function marker potentially linked to systemic inflammation and perfusion status.

This study aims to validate the prognostic value of these biomarkers in predicting the no-reflow phenomenon in STEMI patients undergoing primary PCI.

To validate the clinical utility of selected emerging biomarkers in predicting the no-reflow phenomenon among patients presenting with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years
  • Suitable for and undergoing timely primary PCI based on symptoms and clinical judgment
  • Provision of informed consent

排除标准

  • History of previous MI, PCI, or CABG
  • Known chronic inflammatory or autoimmune diseases
  • Advanced renal or hepatic failure
  • Active infection or malignancy at presentation
  • Incomplete data or refusal to consent

结局指标

主要结局

HbA1c/C-peptide ratio predictive accuracy for no-reflow phenomenon

时间窗: Baseline (prior to PCI)

Diagnostic accuracy of HbA1c/C-peptide ratio for predicting the no-reflow phenomenon in STEMI patients undergoing primary PCI, assessed by area under the ROC curve (AUC).

Neutrophil/HDL ratio predictive accuracy for no-reflow phenomenon

时间窗: Baseline (prior to PCI)

Diagnostic accuracy of neutrophil/HDL ratio for predicting the no-reflow phenomenon in STEMI patients undergoing primary PCI, assessed by area under the ROC curve (AUC).

Albumin-bilirubin (ALBI) score predictive accuracy for no-reflow phenomenon

时间窗: Baseline (prior to PCI)

Diagnostic accuracy of ALBI score for predicting the no-reflow phenomenon in STEMI patients undergoing primary PCI, assessed by area under the ROC curve (AUC).

次要结局

  • Correlation of HbA1c/C-peptide ratio, Neutrophil-to-HDL ratio, and Albumin-Bilirubin (ALBI) score with in-hospital major adverse cardiovascular events (MACE).(Baseline to hospital discharge.)
  • Correlation of HbA1c/C-peptide ratio, Neutrophil-to-HDL ratio, and Albumin-Bilirubin (ALBI) score with 1-month major adverse cardiovascular events (MACE).(Baseline to 1-month follow-up.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hossam Eldin Alaa Abdelhafiz mohamed

Principal investigator, cardiology Department

Assiut University

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