ISSUE3: International Study on Syncope of Uncertain Etiology 3 Pacemaker Therapy for Patients With Asystolic Neurally-mediated Syncope
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 511
- 试验地点
- 2
- 主要终点
- Syncope Recurrence Rate
研究概览
简要总结
ISSUE 3 is a multi-center, prospective, randomised controlled double-blind study aimed to assess the effectiveness of pacemaker therapy for prevention of asystolic neurally-mediated syncope.
详细描述
In asystolic neurally-mediated syncope (NMS) documented by Implantable Loop recorder (ILR), ISSUE-2, an observational trial, showed that pacemaker was effective in reducing the 1-year first syncope recurrence rate from 33% rate before implant (ILR phase 1) to 5% rate after implant (phase 2). Moreover, the control non-asystolic group still continued to have a 41% recurrence rate after the first recurrence of syncope, thus supporting the conclusion that the reduction with pacemaker was due to the beneficial effect of pacemaker itself and not to other factors. However a formal controlled trial is needed to confirm these findings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suspected or certain neurally-mediated syncope, based on the Guidelines recently published by the Task Force on Syncope of the European Society of Cardiology 2,3 (Appendix 1);
- •More than 3 syncope episodes in the last 2 years;
- •Clinical presentation of syncope of sufficient severity requiring treatment initiation in the physician's and patient's judgement.
- •Age > 40 years.
- •Negative carotid sinus massage.
- •Patients accept to have an ILR implantation.
排除标准
- •Carotid sinus hypersensitivity
- •Suspected or certain heart disease and high likelihood of cardiac syncope:
- •Symptomatic orthostatic hypotension diagnosed by standing blood pressure measurement;
- •Loss of consciousness different from syncope (e.g. epilepsy, psychiatric, metabolic, drop-attack, TIA, intoxication, cataplexy);
- •Subclavian steal syndrome;
- •Psychologically or physically (due to any other illness) or cognitively unfit for participation in the study according to the opinion of the investigator;
- •Patient compliance doubtful;
- •Patient geographically or otherwise inaccessible for follow-up;
- •Patient unwilling or unable to give informed consent;
- •Life expectancy <1 year.
结局指标
主要结局
Syncope Recurrence Rate
时间窗: 2 years
Intention to treat analysis of percentage of patients with syncope recurrence at 2 years follow-up after study arm assignement
次要结局
未报告次要终点