Detection of Occult Paroxysmal Atrial Fibrillation in Cryptogenic Stroke Patients or TIA Using an Implantable Loop Recorder and Correlation With Genetic Markers.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Documented Atrial Fibrillation after episode of cryptogenic stroke / TIA Documented genetic mutation PITX2 and ZFHX3
研究概览
简要总结
Atrial fibrillation (AF) is the significant risk factor of ischemic stroke with incidence about 20% of all ischemic strokes. The undiagnosed AF in cryptogenic stroke patients could be present but not revealed by rutinne ECG.
详细描述
The subcutaneous Insertable Cardiac Monitor - Reveal® XT ICM, which provides long-term monitoring ( for 3 years), in selected stroke and TIA population on the basis of age, stroke etiology, and prescreening for cardiac arrhythmias helps to increase a detection of AF to 16.7% (range, 14.3% to 20.0%) in compare to ambulatory ECG detection of AF 6.4% (range, 5.3% to 9.0%). The AF detection after stroke and TIA strategically changes the therapeutic approach. In correlation with mentioned above the incidence of both specific genetic markers of AF and occurance of AF in this population and healthy volunteers are interesting.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cryptogenic stroke or TIA within 72 h of onset symptoms according to the criteria for the Trial of Org 10172 in Acute Stroke Treatment (TOAST )
- •National Institute of Health Stroke scale (NIHSS ) score ≤ 15
- •Modified Rankin Scale (mRS ) score ≤ 3
- •Ability and willingness of patients or their relatives or legal representatives to understand study instructions both verbal and written in accordance with ICH GCP and legislation applicable in the Slovak Republic
排除标准
- •Known etiology of stroke or TIA
- •Untreated hyperthyreosis
- •Myocardial infarct within 1 month of onset stroke or TIA
- •Coronary bypass within 1 month of onset stroke or TIA
- •Valvular disease requiring urgent surgery
- •Documented atrial fibrillation or flutter .
- •Patent Foramen Ovale (PFO)
- •Permanent indication to oral anticoagulation therapy
- •Long-term steroid therapy > 30 days
- •Participation in another clinical trial oriented to experimental pharmacologic therapy .
- •Chronic inflammatory disease ( rheumatoid arthritide, IBD (Inflammatory bowel diseases ), lupus, vasculitis)
- •Severe co-morbidity not likely to complete to follow-up one year
- •Pregnant and breastfeeding women
- •Indication to pacemaker implantation, implantable cardioverter defibrillator (ICD) or Cardiac Resynchronization Therapy IPG or ICD implantation
- •Unabillity provide or unconsent with requiring protocol procedures
结局指标
主要结局
Documented Atrial Fibrillation after episode of cryptogenic stroke / TIA Documented genetic mutation PITX2 and ZFHX3
时间窗: 12 months
Documented Atrial Fibrillation after episode of cryptogenic stroke / TIA Documented genetic mutation PITX2 chromosome 4q25, polymorphism rs1906591,rs10033464 and ZFHX3 chromosome 16q22, polymorphism rs2106261
次要结局
- Time to documented Atrial Fibrillation Reccurent stroke or TIA Stroke Secondary Prevention Therapy changes within 12 months Neuroimaging Changes ( brain CT/ MRI)(12 months)