Comparison Between Epinephrine and Exercise Test in QT Long Syndrome Patients With KCNQ1 or KCNH2 Mutation Without Long QT Interval in Rest ECG
试验速览
- 阶段
- 不适用
- 入组人数
- 130
- 试验地点
- 16
- 主要终点
- to evaluate the best stress exam (exercise test OR epinephrine test)to unmask long QT syndrome.
研究概览
简要总结
The aim of the study is to evaluate the best stress exam to unmask long QT in patient with KCNQ1 or KCNH2 mutation without long QT interval in rest electrocardiogram.
详细描述
65 patients with KCNQ1 or KCNH2 mutation presenting QTc interval <470msec and 65 patients without KCNQ1 or KCNH2 mutation presenting QTc interval <470msec will be included.
All patients will have the 2 tests: exercise test and epinephrine test, in one half day.
At the end of the inclusions, two experts will examine examens results without knowing in which arm (mutated or not) the patient belongs.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with QTc<470 msec, and with molecular analysis (KCNQ1 or KCNH2 genes) performed in order to include 65 patients with KCNQ1 or KCNH2 mutation and 65 patients without KCNQ1 or KCNH2 mutation (controls).
排除标准
- •QTc interval >470msec
- •Treatment interfering with cardiac repolarisation
- •Under 15 years old
- •Pregnant women
- •Contraindication to exercise or epinephrine tests
- •Patients without social coverage
结局指标
主要结局
to evaluate the best stress exam (exercise test OR epinephrine test)to unmask long QT syndrome.
时间窗: day 1
Exercise test and epinephrine test will be done at inclusion (day 1). The primary outcome of this study is to evaluate the best stress exam (exercise test versus epinephrine test), defined by a "positive" test to unmask long QT syndrome. Test is positive when QT interval lengthens 30 ms At the end of study inclusions, two reviewers will analyse, independently, electrocardiograms resulting from these tests to determine for each patient if a test was positive and which one. These reviewers will do this job without being informed of the patient status (mutated patient or not mutated patient (control)).
次要结局
- to evaluate each test characteristics(Day 1)