Vascular Health and Risk Factors in Children With Down Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- The difference in mean pulse wave velocity between children with Down syndrome and published national data in children without Down syndrome at one time point.
研究概览
简要总结
This is a prospective, multicenter, cross-sectional study to evaluate prevalence of vascular risk factors in children with Down Syndrome and to determine the association between vascular disease risk factors and objective markers of early atherosclerosis.
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
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All children with Down Syndrome (10.0-18.0 years of age)
- •Children with translocations and mosaicism
- •Children with and without CHD
排除标准
- •Patients with a history of hypoplastic arch, coarctation or catheter or surgical based aorta interventions
- •Patients who are currently treated or have been treated with chemotherapy for cancer or a myeloproliferative disorder within 1 year of the study
- •Participants whose parent/legally authorized representative (LAR) perceives the child is not able to cooperate with vascular imaging studies
结局指标
主要结局
The difference in mean pulse wave velocity between children with Down syndrome and published national data in children without Down syndrome at one time point.
时间窗: One day patient visit
Pulse wave velocity (PWV) is a non-invasive imaging measure of arterial stiffness. Pulse wave velocity measures vascular stiffness by evaluating the time for a pressure wave to travel through the aorta. The velocity is determined by the elasticity and geometry of the vessel. PWV will be measured using a SphygmoCor device. With the participant in the supine position and ECG leads attached, the maximal pulsation of the right carotid and right femoral artery will be marked and measured from the suprasternal notch using a tape measure (carotid) and caliper (femoral). A tonometer will record the carotid and femoral impulses. The device calculates PWV as the difference in the carotid-to-distal path length divided by the difference in R-wave-to-waveform times (∆distance/∆time, m/sec). Measurements will be in triplicate and averaged. PWV can be completed in \~30 mins.
次要结局
- Correlation of serologic cardiovascular risk factors include insulin resistance on PWV and CIMT in children with Down syndrome.(One day patient visit)
- Correlation of waist circumference anthropometric cardiovascular risk factors on PWV and CIMT in children with Down syndrome.(One day patient visit)
- Correlation of serologic cardiovascular risk factors include lipoprotein on PWV and CIMT in children with Down syndrome.(One day patient visit)
- The difference in mean carotid intimal medial thickness between children with Down syndrome and published national data in children without Down syndrome measured at 1 time point.(One day patient visit)
- Correlation of body mass index (BMI) anthropometric cardiovascular risk factors on PWV and CIMT in children with Down syndrome.(One day patient visit)
- Correlation of serologic cardiovascular risk factors include fasting lipid panel on PWV and CIMT in children with Down syndrome.(One day patient visit)
- Correlation of clinical cardiovascular risk factors on PWV and CIMT in children with Down syndrome.(One day patient visit)
研究者
Adam Ware
MD, Assistant Professor, Pediatric Cardiology
University of Utah