ISRCTN45146526已完成不适用
Randomised trial of optimal conventional therapy versus optimal conventional therapy plus counterpressure manoeuvres in patients with neurally-mediated syncope
Academic Medical Center (AMC) (The Netherlands)0 个研究点目标入组 200 人开始时间: 2005年12月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Clinical diagnosis of classical neurally-mediated reflex syncope, based on the medical history or non-classical diagnosis of neurally-mediated reflex syncope and a positive tilt-table test
- •2. Three syncope episodes in the last two years or at least one syncopal spell in the last year and at least three episodes of presyncope in the last year
- •3. Recognisable prodromal symptoms
- •4. Aged 16 - 70 years
排除标准
- •1. Suspected or certain heart disease and high likelihood of cardiac syncope:
- •1.1. Syncope preceded by palpitations or precordial pain
- •1.2. Syncope during exercise
- •1.3. Heart failure
- •1.4. Ejection fraction less than 40%
- •1.5. Old or recent myocardial infarction
- •1.6. Hypertrophic cardiomyopathy
- •1.7. Dilated cardiomyopathy
- •1.8. Significant valvular disease
- •1.9. Sinus bradycardia less than 50 bpm or sino-atrial blocks
- •1.10. Mobitz I second degree atrioventricular block
- •1.11. Mobitz II 2nd or 3rd degree atrioventricular block
- •1.12. Complete bundle branch block
- •1.13. Rapid paroxysmal supraventricular tachycardia or ventricular tachycardia
- •1.14. Pre-excited QRS complexes
- •1.15. Prolonged QT interval
- •1.16. Right bundle branch block pattern with ST-elevation in leads V1-V3 (Brugada syndrome)
- •1.1.7. Negative T waves in right precordial leads, epsilon waves and ventricular late potentials suggestive of arrhythmogenic right ventricular dysplasia)
- •2. Orthostatic hypotension
- •3. Episodes of loss of consciousness different from syncope (e.g. epilepsy, psychiatric, metabolic, drop-attack, transient ischemic attack [TIA], intoxication, cataplexy)
- •4. Steal syndrome
- •5. Psychologically or physically (due to any other illness) or cognitively unfit for participation in the study according to the opinion of the investigator
- •6. Patient compliance doubtful
- •7. Patient geographically or otherwise inaccessible for follow-up
- •8. Patient unwilling or unable to give informed consent
- •9. Pregnancy
- •10. Life expectancy less than one year
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