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临床试验/NCT05782712
NCT05782712已完成不适用

Rapid Measurement of Adenosine Concentration in Patients With Syncope

Istituto Auxologico Italiano1 个研究点 分布在 1 个国家目标入组 235 人开始时间: 2021年10月4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
235
试验地点
1
主要终点
Adenosine dosage

研究概览

简要总结

Until now, a barrier to the widespread evaluation of adenosine in clinical practice has been the difficulty of obtaining rapid reliable measures. A rapid method has recently been developed which consists of measuring adenosine concentration in whole blood instead of plasma by means of Mass Spectrometry (LC-MS/MS). In this study adenosine plasma levels were assessed in a larger unselected cohort of patients affected by non-cardiac syncope and compared the results with healthy controls.

详细描述

Rationale and aim Until now, a barrier to the widespread evaluation of adenosine in clinical practice has been the difficulty of obtaining rapid reliable measures. Indeed, owing to its short half-life in the blood, adenosine is not easy to sample and measure. At the time of venepuncture, a stop solution - not commercially available - must be utilized in order to inhibit the degradation of adenosine in body fluid. After plasma deproteinization, adenosine concentration is evaluated by means of high-performance liquid chromatography.

A rapid method has recently been developed which consists of measuring adenosine concentration in whole blood instead of plasma by means of Mass Spectrometry (LC-MS/MS). In brief, whole blood is collected after finger puncture and a drop is deposited on a blot paper (Whatman). After the extraction of adenosine by means of a mixture consisting of methanol and internal standard, its concentration is measured by LC-MS/MS. This method is rapid, well accepted by the patient, not expensive, and easily replicable. Comparison between the two above-mentioned methods in 20 healthy subjects and in patients with vasovagal syncope has shown an acceptable correlation, with a r=0.65 and p<0.01. The mean adenosine concentration was significantly higher in vasovagal syncope patients than in controls (3.1 µM versus 0.60 µM, p<0.001). However, the above results need to be replicated in a larger sample of patients and controls before the blot paper method of measurement of adenosine can replace the standard method.

In this study denosine plasma levels was assessed in a larger unselected cohort of patients affected by non-cardiac syncope and compared the results with healthy controls.

Study design The rapid method of adenosine dosage in whole blood was assessed in patients with syncope and in controls. The study was performed in patients referred to Istituto Auxologico Italiano. The blood sample was be shipped to the Laboratory of Biochemistry, Timone Hospital 264 Rue Saint-Pierre, 13385 Marseille, France for analysis Syncope group: patients referred to the Syncope Unit of Auxologico with a diagnosis of possible or certain reflex syncope (class I diagnostic criteria of ESC guidelines) after exclusion of competing diagnoses.

There syncope patients are subdivided in 3 predefined subgroups:

研究设计

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

入排标准

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

入选标准

  • patients referred to the Syncope Unit of Auxologico with a diagnosis of possible or certain reflex syncope (class I diagnostic criteria of ESC guidelines)

排除标准

  • exclusion of competing diagnoses.

结局指标

主要结局

Adenosine dosage

时间窗: 2 hours

Comparison of plasmatic adenosine value observed in the syncope group with that of control group

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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