NL-OMON54431已完成不适用
A study to describe the effectiveness of arrhythmia analysis software for screening of Sinus rhythm, Atrial Fibrillation and premature beats in light skin-and dark skin tone patients - Huawei Afib study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Age >18 of any sex; 2. Wrist circumference 140 mm - 210 mm; 3.
- •Fitzpatrick skin type 1, 2, 5, or 6 (pre-screening); 4. Melanin Index (MI)
- •<150 or >350 as measured on the inner arm; 5. One of the following
- •conditions, based on past 3 months' history or screening electrocardiogram: a.
- •Normal sinus rhythm; b. Persistent or permanent or onset atrial fibrillation;
- •c. Frequent (>5 beats per minute) premature beats or ongoing premature
- •beats; 6. Willing and able to provide voluntary, written informed consent.
排除标准
- •1. Patients using pacemakers or implantable cardioverter defibrillators (ICDs);
- •2. Patients with atrioventricular block or bundle branch block;
- •3. Patients with sinus tachycardia, significant sinus bradycardia, significant
- •sinus arrhythmia, sinus arrest or sick sinus syndrome;
- •4. Interpositional premature beats, dual-law premature beats, triple-law
- •premature beats, border premature beats or escape beat heart rhythm patients;
- •5. Patients with atrial tachycardia, atrial flutter, ventricular tachycardia,
- •ventricular flutter or ventricular fibrillation;
- •6. Patients with resting heart rate less than 50 times/minute or more than 110
- •times/minute;
- •7. Patients with tremor disease or chorea disease that are difficult to
- •cooperate in completing the examination while remaining still;
- •8. Bullous disease or generalized rash, and other patients not suitable for
- •surface electrode recording;
- •9. Patients with skin allergies to alcohol;
- •10. Patients with skin infectious diseases;
- •11. Patients with a history of mental illness or cognitive impairment;
- •12. Patients who have participated in other clinical trials that may affect
- •this trial within the past 30 days;
- •13. Concomitant medication that might interfere with study results;
- •14. Other situations where the researchers consider it inappropriate for a
- •patient to take part in the trial.
研究者
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