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临床试验/NCT05174390
NCT05174390Unknown不适用

Thumb ECG IncidenT Atrial fibrillatioN in Diabetes Mellitus

Region Gävleborg1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2021年9月20日最近更新:
适应症

试验速览

阶段
不适用
入组人数
600
试验地点
1
主要终点
Number of participants with the diagnosis of atrial fibrillation

研究概览

简要总结

Cardiac thromboembolism attributed to atrial fibrillation (AF) constitutes at least one-third of ischemic strokes. Indeed, stroke may be the first manifestation of previously undetected AF. The prevalence is projected to increase 20% the coming decades, especially in age group 65 years and above of age. To add to incidence, the diabetic population have an increased risk yet not properly investigated. In patients with confirmed AF, assessment using the CHA2DS2-VASc score (congestive heart failure, hypertension, age 65 years and above, diabetes mellitus, stroke, vascular disease, age 75 years and above, sexual category), is applied for risk stratification. If the CHA2DS2-VASc score is at least 1, or definitely 2 points typically a non-vitamin K antagonist oral anticoagulant (NOAC) should be prescribed. The chest- and thumb-electrocardiogram (ECG) system Coala Heart Monitor has proven efficacious in detecting AF following recent cryptogenic stroke. This system also showed to be feasible from a patient perspective. Thus, in patients aged 65 years and above with diabetes mellitus at least 2 points are reached. Therefore, patient with these risk factors should be considered for further evaluation for NOAC to prevent stroke, which provides the rational for this study.

详细描述

Cardiac thromboembolism attributed to atrial fibrillation (AF) constitutes at least one-third of ischemic strokes.The prevalence is projected to increase 20% the coming decades, especially in age group 65 years and above of age. To add to incidence, the diabetic population have an increased risk yet not properly investigated. In patients with confirmed AF, assessment using the CHA2DS2-VASc score (congestive heart failure, hypertension, age 65 years and above, diabetes mellitus, stroke, vascular disease, age 75 years and above, sexual category) , is applied for risk stratification. If the CHA2DS2-VASc score is at least 1, or definitely 2 points typically a Non-vitamin K antagonist Oral AntiCoagulants (NOAC) should be prescribed. The chest- and thumb-electrocardiogram (ECG) system Coala Heart Monitor will be used to detect AF, which showed to be feasible from a patient perspective. Thus, in patients aged 65 years and above with diabetes mellitus at least 2 points are reached. Therefore, patient with these risk factors should be considered for further evaluation for NOAC to prevent stroke, which provides the rational for this study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 65 years and above
  • Diabetes mellitus (both type 1 and type 2)

排除标准

  • Treatment with anticoagulation (Eliquis, Lixiana, Pradaxa, Xarelto, Waran)
  • Pacemaker, implantable cardioverter defibrillator, insertable cardiac monitor
  • Not able to participate in 90 days follow-up

结局指标

主要结局

Number of participants with the diagnosis of atrial fibrillation

时间窗: 90 days

Incidence of atrial fibrillation during the monitoring period

次要结局

  • Patient-reported symptoms (descriptive category variables) of atrial fibrillation using a questionnaire in a digital application(90 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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