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临床试验/NCT04240067
NCT04240067已完成不适用

Multimarker Approach for Acute Dyspnea in Elderly Patients Admitted in the Emergency Department

Centre Hospitalier Universitaire de Besancon1 个研究点 分布在 1 个国家目标入组 238 人开始时间: 2016年9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
238
试验地点
1
主要终点
To assess the diagnostic performance of the multimarker approach (combining NT-proBNP, High-sensitivity Troponin-I, ST2 and Galectin-3) for the diagnosis of ALSHF in patients aged ≥75 years admitted to the ED for acute dyspnea

研究概览

简要总结

Elderly people constitute the largest proportion of emergency department (ED) patients, representing 12% of all ED admissions. The need for diagnostic tests or therapeutic interventions is much greater in this patient population. Cardiovascular diseases and symptoms represent 12% of the causes for ED admission, and patients suffering from cardiovascular disease are those whose ED visit lasts longest.

The diagnostic approach in the ED in elderly patients admitted for acute dypsnoea is complex, and early identification of acute left-sided heart failure (ALSHF) is vital as it has an impact on prognosis. The clinical signs are difficult to interpret, and are non-specific, particularly at the acute phase and in elderly or obese patients. Indeed, some authors have reported up to 50% of diagnostic errors in elderly patients.

Measure of the blood concentration of a natriuretic peptide allows a quick diagnosis. However, peptides alone suffer from several limitations, particularly in situations that are often encountered in elderly patients, such as sepsis, renal failure, acute coronary syndrome, pulmonary embolism, chronic respiratory failure, atrial fibrillation and high body mass index. Diagnostic performance deteriorates with increasing age, and there is a significant increase in this grey-zone in patients aged ≥75 years. In critical situations in elderly patients, assessment of natriuretic peptides serve mainly to rule out a diagnosis of left heart failure.

Some authors have studied other biomarkers showing their performance in the diagnosis of ALSHF. These are biomarkers involved in remodeling and myocardial fibrosis (ST2, Galectin-3) or involved in myocardial injury (High-sensitivity Troponin-I).

Therefore, a combined "multimarker" approach could improve the diagnostic performance of ALSHF.

READ (NCT02531542) is a diagnostic study including patients over the age of 75 admitted to acute dyspnea in the ED, to demonstrate the superiority of an ultrasound protocol (the READ protocol) on NT-proBNP in the ALSHF diagnosis.

The hypothesis is that the diagnostic accuracy of a multimarker diagnostic approach, namely the READ-MA method, combining NT-proBNP, High-sensitivity Troponin-I, ST2 and Galectin-3 would be superior to that of NT-proBNP assessment for the diagnosis of ALSHF in elderly patients (≥75 years) admitted to the ED.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

To assess the diagnostic performance of the multimarker approach (combining NT-proBNP, High-sensitivity Troponin-I, ST2 and Galectin-3) for the diagnosis of ALSHF in patients aged ≥75 years admitted to the ED for acute dyspnea

时间窗: 1 day

1. The presence or absence of ALSHF (gold standard used in the READ study) : diagnosis by 2 experts (cardiologist and emergency physician) based on data collected in the ED and during hospitalization, biological assays (except NT-proBNP) and echocardiography performed by a cardiologist. 2. The positivity of the evaluated test (multi-marker approach) : * For NT-proBNP, the threshold for positivity is higher than 1800 pg/mL. There is no consensus for High-Sensitivity Troponin-I, ST2 and Galectin-3. Firstly, the optimal threshold of each of these 3 biomarkers will be assessed by ROC curve, then the best combination between these 4 biomarkers will be tested to obtain an optimal discrimination (sensitivity, specificity positive and negative predictive values), positive and negative likelihood ratios) using various methods.

次要结局

  • To demonstrate the superiority of the multimarker approach (NT-proBNP, High-sensitivity Troponin-I, ST2 and Galectin-3) over NT-proBNP alone for the diagnosis of ALSHF in patients aged ≥75 years admitted to the ED for acute dyspnea(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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