Thumb ECG IncidenT Atrial fibrillatioN in Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Thumb ECG IncidenT Atrial fibrillatioN in Diabetes Mellitus

Conditions
-----------------
Diabetes Mellitus, Atrial Fibrillation

Intervention / Treatment
-----------------
* Diagnostic Test: Coala Heart Monitor Pro


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 65 years and above Diabetes mellitus (both type 1 and type 2) Exclusion Criteria: Treatment with anticoagulation (Eliquis, Lixiana, Pradaxa, Xarelto, Waran) Pacemaker, implantable cardioverter defibrillator, insertable cardiac monitor Not able to participate in 90 days follow-up

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Coala Heart Monitor Pro|thumb- and chest-ECG|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with the diagnosis of atrial fibrillation | Incidence of atrial fibrillation during the monitoring period | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported symptoms (descriptive category variables) of atrial fibrillation using a questionnaire in a digital application | Symptoms (questionnaire with the following categories of answers: palpitation, dizziness, dyspnea, chest pain, other) when atrial fibrillation is diagnosed using the patient report (in the digital application with the mentioned categories of symptoms predefined) at the time of ECG transmission. | 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atrial fibrillation, diabetes mellitus, thumb-ECG