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临床试验/NCT06733961
NCT06733961已完成不适用

Investigation of the Relationship of SCUBE-1 and VAP-1 Levels on Diagnosis, Prognosis and Clinical Results in Patients with Pulmonary Thromboembolism Diagnosis in Emergency Department

Giresun University1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
88
试验地点
1
主要终点
Diagnostic ability of SCUBE-1 and VAP-1 in pulmonary embolism

研究概览

简要总结

Acute pulmonary thromboembolism is a life-threatening disease. Clinical suspicion is essential for diagnosis because of lack of a specific finding for diagnosis of PTE. The aim of this study is to investigate the relationship between the diagnosis and prognosis of alternative biomarkers such as SCUBE-1 and VAP-1 in the diagnosis of clinically suspected acute PTE.

Patients who were admitted to the Emergency Department and diagnosed as acute PTE were included in the study. Patients with acute ischemic disease, liver failure, renal failure, pregnancy, active malignancy and/or history of known PTE were excluded from the study. A control group was formed from healthy volunteers at similar age and sex. SCUBE-1 and VAP-1 levels were studied from serum samples taken from the patient and control groups. Data were analyzed using by IBM SPSS V23.

详细描述

The definitive diagnosis of APT is made by ventilation/perfusion (V/Q) scintigraphy and thorax computed tomography angiography (CTA). There is no specific examination as a laboratory parameter. A definitive diagnosis cannot be made with d-Dimer, which is the most frequently used laboratory test today; it is used to exclude the diagnosis of APT.

The non-specificity of the clinical picture, the fact that the diagnosis depends on the experience of the physician and the necessity of exposure to radiation and contrast material for the definitive diagnosis has revealed the necessity of searching for alternative ways for the diagnosis of APT. "Signal peptide CUB-EGF domain-containing protein-1" (SCUBE-1) is a biomarker released during platelet aggregation, and "Vascular adhesion protein-1" (VAP-1) is a biomarker released from endothelium, and these biomarkers show promise for the diagnosis of APT.

Determination of serum SCUBE-1 and serum VAP-1 levels 5 mL blood taken from the peripheral veins of the patients was placed in a biochemistry tube and centrifuged at 3000 g. After centrifugation, the serum part of the blood was separated and taken into an eppendorf tube and stored in an ultra-deep freezer at minus 80°C until the study day. Before starting the study, the ELISA kits kept at 2-8°C and the samples kept in an ultra-deep freezer at minus 80°C were brought to room temperature.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • being older than 18 years of age
  • presenting to the emergency department,
  • diagnosed with acute PTE by contrast-enhanced computed tomography angiography

排除标准

  • having acute ischemic disease, liver, kidney or advanced heart failure, liver disease, pregnancy, active malignancy or hematological disease, and a known history of PTE.

结局指标

主要结局

Diagnostic ability of SCUBE-1 and VAP-1 in pulmonary embolism

时间窗: 6 month

Serum SCUBE-1 and serum VAP-1 levels of the Patient and Control groups will be measured in serum mg/dL with 5 mL of blood taken from the peripheral veins.

次要结局

  • Difference between clinical probability scores and serum SCUBE-1 and VAP-1 levels.(6 month)
  • difference between early mortality risk and serum SCUBE-1 and VAP-1 levels.(28 days)

研究者

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

İskender Aksoy

Assistant Professor

Giresun University

研究点 (1)

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