Invasive Hemodynamic Cardiopulmonary Exercise Testing for Assessment of Patients With Congenital Heart Disease (Cath CHD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in right ventricular free-wall strain from rest to peak exercise
研究概览
简要总结
The purpose of this study is to compare the difference in the ability to detect hemodynamic abnormalities between invasive hemodynamic assessments performed at rest versus exercise, to assess the correlation between invasive and noninvasive (Doppler-derived) rest-exercise hemodynamic indices and to compare the association between indices of disease severity and hemodynamic abnormalities identified at rest versus exercise.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Congenital Heart Disease Diagnosis
- •Undergoing Clinically indicated Cardiac Cath
排除标准
- •Unable to consent
- •Pregnancy
研究组 & 干预措施
Patients Undergoing Clinically indicated Cardiac Cath
干预措施: Cardiac Cath (Procedure)
结局指标
主要结局
Change in right ventricular free-wall strain from rest to peak exercise
时间窗: Baseline
Change in right ventricular free-wall strain will be measured in Δ%
Change in pulmonary vascular resistance from rest to peak exercise
时间窗: Baseline
Change in pulmonary vascular resistance will be measured in ΔWoods Units
Change in left ventricular end-systolic elastance from rest to peak exercise
时间窗: Baseline
Change in left ventricular end-systolic elastance will be measured in ΔmmHg/mL
Change in systemic vascular resistance from rest to peak exercise
时间窗: Baseline
Change in systemic vascular resistance will be measured in ΔWoods Units
Change in Left ventricular cardiac output from rest to peak exercise
时间窗: Baseline
Change in left ventricular cardiac output will be measured in ΔL/min
Change in right ventricular cardiac output from rest to peak exercise
时间窗: Baseline
Change in right ventricular cardiac output will be measured in ΔL/min
次要结局
未报告次要终点
研究者
Alexander C. Egbe
Principal Investigator
Mayo Clinic