Cardiovascular Magnetic Resonance in Adults With SysTemic Right Ventricle (STAR): From Pathophysiology to Clinical Application
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Adverse Outcome definition
研究概览
简要总结
The main aim of the study is to explore HFs in SRV, comparing their magnitude and direction with that of subpulmonary RV and systemic LV. As a secondary aim, possible association or correlation will be investigated between SRV energetics and: i) patient functional parameters, e.g., the results from cardiopulmonary exercise test (CPET), ii) patient clinical status, including the occurrence of adverse outcome (a composite of death, hospitalization for heart failure, cardiovascular arrest, sustained arrhythmias).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Case group:
- •The study will include patients aged ≥ 18 years with the diagnosis of L-TGA and D-TGA, who:
- •are admitted to UNICCA, the Adult Congenital Heart Unit or
- •are scheduled for a Cardiovascular Magnetic Resonance examination in this Institution
- •Control group:
- •The study will include subjects aged ≥ 18 years who will invited for a Cardiovascular Magnetic Resonance examination in our Institution. This group of control will include n=15 of adult healthy subjects. A further inclusion criteria for the control subjects are age and male proportion comparable to those of the TGA group.
排除标准
- •(case and control group)
- •Subjects with intrabody ferromagnetic material precluding subject's safety
- •Subjects with non CMR-conditional devices
- •Subjects with claustrophobia or breath-holding precluding an adequate CMR and 4D Flow images quality
- •Pregnant women
结局指标
主要结局
Adverse Outcome definition
时间窗: 5 years
A composite of death, hospitalizations for heart failure, cardiovascular arrest, sustained arrhythmias (≥30 seconds).
次要结局
未报告次要终点
研究者
Giulia Pasqualin
Principal Investigator
IRCCS Policlinico S. Donato
