Predictive Accuracy of YEARS Score in Diagnosis of Pulmonary Embolism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- YEARS score vs CTPA in diagnosis of PE
研究概览
简要总结
The investigators' aim in this study is to assess the sensitivity and accuracy of YEARS algorithm in the diagnosis of PE.
详细描述
Pulmonary embolism (PE) is a relatively common acute cardiovascular disorder with high early mortality rates that, despite advances in diagnosis and treatment over the past 30 years, have not changed significantly. Due to pulmonary bed obstruction, PE can result in acute right ventricular (RV) failure. Because most patients ultimately die within the first hours of presentation, early diagnosis is of paramount importance.
The incidence of PE is estimated to be approximately 60 to 70 per 100,000, and that of venous thrombosis approximately 124 per 100,000 of the general population.
Because of its diagnostic accuracy and wide availability, multidetector row computed tomography pulmonary angiography (CTPA) is the imaging test of choice to confirm acute pulmonary embolism in most patients. Increasing use of CTPA with diminishing prevalence of pulmonary embolism to even less than 10% has led to overdiagnosis of mostly subsegmental pulmonary embolism and unnecessary risks of radiation exposure and contrast medium induced nephropathy.
To avoid these problems, validated diagnostic algorithms for suspected acute pulmonary embolism, using sequential testing, have been introduced. In these algorithms, a normal D-dimer test result in patients with low probability safely excludes pulmonary embolism.
YEARS scoring system is an algorithm to predict diagnosis of pulmonary embolism according to clinical signs and D-dimer. The aim of this study is to test predictive accuracy, sensitivity and specificity of YEARS score compared to CTPA in the diagnosis of PE as CTPA is an invasive procedure, expensive and not readily available in many settings, thus, finding an alternative easier method that can diagnose PE may help save the time and resources.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient more than 18 years old presenting to the emergency room with symptoms of clinically suspected pulmonary embolism such as:
- •Sudden onset of dyspnea, sudden deterioration of existing dyspnea, sudden onset of pleuritic chest pain without another apparent cause.
- •Any other symptoms like hemoptysis, syncope or unilateral leg pain.
排除标准
- •Pregnancy
- •Allergy to intra-venous contrast agents
- •Renal insufficiency (creatinine clearance < 30 mL/min).
结局指标
主要结局
YEARS score vs CTPA in diagnosis of PE
时间窗: One year
In patients with no YEARS items and a D-dimer concentration less than 1000 ng/mL, pulmonary embolism was considered excluded and further testing was withheld. In patients with one or more YEARS items and a D-dimer concentration less than 500 ng/mL, pulmonary embolism was also considered excluded and further testing was withheld. All other patients i.e., either with no YEARS item and a D-dimer concentration of 1000 ng/mL or more, or with one or more items and a concentration of 500 ng/mL or more were referred for CTPA to show or exclude the diagnosis of pulmonary embolism.
次要结局
未报告次要终点
研究者
Hussien Fayiad
Clinical Professor
Kasr El Aini Hospital