Non-invasive Quantification of Atrial Fibrosis by MRI in Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- quantitative measure of atrial fibrosis
研究概览
简要总结
Three groups of patients will be considered: a control group (n = 10); a group of patients with paroxysmal or persistent AF with AF cryoablation procedure - within this group, MRI will replace CT-scan usually performed in routine before the procedure (n = 15); a group of patients with permanent AF (n = 15). MRI study will include pulmonary veins angiography with gadolinium injection (0.20 mmol/kg), 2D-cine imaging and late-enhancement imaging. A 3D gradient-echo sequence(Flash 3-D) will then be applied 20 minutes after the injection, with the following parameters : echo time 0.98 ms, repetition time 2.53 ms, angle 15°, resolution 2.0x1.3x1.0 mm. T1 map and two T2 sequences will be performed so as to determine LA relaxation times. Argus software will be used for post-treatment imaging. Quantitative data will be expressed in mean ± SD. A comparison of T1 and T2 values in LA will be performed between the three groups. Statistics will be performed with SPSS software in bilateral analysis and a value of p < 0.05 will be considered as significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •All persons > 18 years, which have:
- •gp paroxysmal or persistant FA
- •paroxysmal or persistent FA (under one year),
- •refractory to at least one antiarrhythmic drug therapy
- •eligible for an ablation procedure with cryotherapy
- •the patient may benefit from surveillance. gp permanent FA permanent AF ( defined as chronic arrhythmia after 2 failed attempts to electrical cardioversion and / or more than one year old) , and hospitalized for cardiac reasons or not in different cardiology Timone .
排除标准
- •age < 18 years,
- •cons -indications to MRI ( claustrophobia, pacemakers and implantable cardiac defibrillators , metal chips intra ocular , valvular mechanical prosthesis ) , allergy to gadolinium ,
- •renal impairment ( creatinine clearance <60 mL / min)
- •pregnant or nursing ( a pregnancy test must be performed for women of childbearing age at the time of inclusion , the result of this test will be communicated to them .
- •the MRI examination takes place three months after the inclusion women of childbearing potential should be placed under effective contraception)
研究组 & 干预措施
a control group
干预措施: MRI 3T (Device)
patients with paroxysmal or persistent AF
干预措施: MRI 3T (Device)
patients with permanent AF
干预措施: MRI 3T (Device)
结局指标
主要结局
quantitative measure of atrial fibrosis
时间窗: 4 years
次要结局
未报告次要终点