跳至主要内容
临床试验/NCT00722826
NCT00722826已完成不适用

MRI Assessment of Right Ventricular Function in Patients After Repair of Tetralogy of Fallot

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2007年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
82
试验地点
1

研究概览

简要总结

Patients with pulmonary regurgitation after surgical correction of ToF over 13 years old will be recruited from the UCSF adult congenital heart disease clinic. Since there is no data in the literature describing the prevalence of abnormal MRI volumetric and functional parameters in asymptomatic patients with PR after ToF repair, a pilot study with 30 patients will be conducted. Increase in sample size may be necessary in the future to accurately interpret the data. After informed consent is obtained, clinical history and physical examination as well as review of old charts will be performed to characterize these patient's clinical status. All patients will undertake a graduated supine bicycle exercise test with MVO2 measurement to assess exercise capacity.

MRI studies will be performed in a 1.5 tesla unit. SSFP cine images will be obtained in the short-axis plane encompassing the entire heart. Velocity-encoded cine MR images will be obtained perpendicular to the direction of blood flow in the main pulmonary artery. Volumetric and flow analysis will be performed in a separate dedicated workstation by a radiologist. End-diastolic volume, end-systolic volume, ejection fraction, total ejection fraction and pulmonary regurgitant fraction will be calculated.

研究设计

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

入排标准

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

入选标准

  • Patients over 13 years of age with pulmonary regurgitation after surgical correction of tetralogy of Fallot.
  • Adult patients with pulmonary regurgitation after surgical repair of tetralogy of Fallot who are under follow-up at the adult congenital heart disease clinic at UCSF or
  • Pediatric patients with pulmonary regurgitation after surgical repair of tetralogy of Fallot who are under follow-up at the pediatric congenital heart disease clinic at UCSF and are referred for a clinically indicated cardiac MRI studies or
  • Adult and pediatric patients with pulmonary regurgitation after surgical repair of tetralogy of Fallot who are referred for clinically indicated MRI studies at UCSF.

排除标准

  • Contraindication for MRI study. Claustrophobia.

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验