Normal Variation of T1 Values With Cardiac Magnetic Resonance in Healthy Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Change of T1 values (substudy 2)
研究概览
简要总结
The purpose of the study is to determine the normal variation of T1 values with cardiac magnetic resonance in healthy individuals with respect to reproducibility, changes over time, and dependency on hydration status.
详细描述
T1 mapping with cardiac magnetic resonance (CMR) is a novel non-invasive technique to quantitatively characterize the myocardium. T1 mapping is a surrogate marker of myocardial edema and fibrosis, and has the potential to be implemented in the diagnosis and follow-up of various cardiac diseases. However, there is limited data on the natural variation of T1 mapping in healthy individuals.
The study comprises three substudies:
- Reproducibility: Two identical CMR examinations with T1 mapping will be performed on the same day .
- Hydration changes: Participants will receive two liters of isotonic saline intravenously between two identical CMR with T1 mapping and echocardiographic examinations. The post-fluid order of CMR and echocardiography will be randomized.
- Time changes: Participants will undergo CMR with T1 mapping at baseline, at 6-months follow-up, and at 1-year follow-up.
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 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-89 years
排除标准
- •Chronic disease (e.g. cardiovascular disease, rheumatological disease, lung disease)
- •Medications affecting the cardiovascular system (e.g. antihypertensives, statins, anticoagulants)
- •Contraindications for CMR (claustrophobia, pregnancy, magnetic metallic implants)
结局指标
主要结局
Change of T1 values (substudy 2)
时间窗: Through study completion, an average of 1 year
Change in T1 values after fluid administration
Change in T1 values (substudy 3)
时间窗: Through study completion, an average of 1 year
Change in T1 values over time (baseline, 6 months, 1 year)
Change in T1 values (substudy 1)
时间窗: Through study completion, an average of 1 year
Change in T1 values between two consecutive scans on the same day
次要结局
未报告次要终点
研究者
Katrine Aagaard Myhr
Principital Investigator
Rigshospitalet, Denmark