Cardiac Murmurs in Children: Predictive Value of Cardiac Markers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Number of patients with any congenital heart disease as assessed by echocardiography
研究概览
简要总结
Heart murmurs are commonly discovered in young children during clinical encounters in general practice. Heart murmurs might signal a structural cardiac disease that need to be treated, such as atrial septal defect. Thus, children with heart murmurs are routinely referred to comprehensive cardiac examination at a paediatric hospital department featuring echocardiography ('gold standard'). However, the great majority of such murmurs are innocent or physiological; ie., they do not represent a cardiac disorder. The prevalence of such innocent murmurs during routine random auscultation is estimated at 30 %.
It would be advantageous if patients with a heart disease to a greater extent could be identified at the general practitioners' office:
- Healthy children would not be exposed to comprehensive cardiac examination
- The burden on the family would subside.
- Scarce medical resources in highly specialized departments would be better allocated, to the benefit of patients with real heart disease.
The primary aim of this study is to establish the predictive value of cardiac markers in children with heart murmurs. Secondary aims are a) To do a pilot study of pediatric cardiac ultrasound examination in general practice; b) To establish age-adjusted reference range for cardiac markers in children, and c) To explore aspects of cardiovascular physiology in children.
The investigators will include a total of 500 children aged 4 weeks to 10 years who is consecutively referred to the Dept. of Paediatrics, Akershus University Hospital, for assessment of heart murmurs. All participants will be subjected to clinical examination, symptom assessment, pulse oximetry, blood sampling (for troponin T, proBNP and other biomarkers), ECG recording, and echocardiography. A randomized subgroup of children will also undergo echocardiography performed by a general practitioner who has not received formal training in pediatric cardiology. The value of possible predictors will be assessed through the construction of Receiver Operating Characteristics (ROC) curves, and calculation of negative predictive value.
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
- 4 Weeks 至 10 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spontaneously discovered heart murmur at general practitioner's office
排除标准
- •Known cardiac disease
- •Other chronic or acute disorder
- •Medications
结局指标
主要结局
Number of patients with any congenital heart disease as assessed by echocardiography
时间窗: 1 day
次要结局
未报告次要终点
研究者
Vegard Wyller
Professor
University Hospital, Akershus
