跳至主要内容
临床试验/NCT05690854
NCT05690854招募中不适用

Cardiovascular Magnetic Resonance in Adults With SysTemic Right Ventricle (STAR): From Pathophysiology to Clinical Application

IRCCS Policlinico S. Donato1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年11月29日最近更新:
适应症

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

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

发起方
IRCCS Policlinico S. Donato
申办方类型
Other
责任方
Principal Investigator
主要研究者

Giulia Pasqualin

Principal Investigator

IRCCS Policlinico S. Donato

研究点 (1)

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