Thumb ECG IncidenT Atrial fibrillatioN in Diabetes Mellitus

• Conditions: Diabetes Mellitus; Atrial Fibrillation

• Registration Number: NCT05174390
• Lead Sponsor: Region Gävleborg

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.

Study Timeline

• Study Start: 2021-09-20
• Status Verified: 2021-11
• Study First Submitted: 2021-11-30
• Study First Submitted QC: 2021-12-13
• Last Update Submitted: 2021-12-13
• Study First Posted: 2021-12-30
• Last Update Posted: 2021-12-30
• Primary Completion: 2022-04-20
• Study Completion: 2022-06-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with the diagnosis of atrial fibrillation	90 days	Incidence of atrial fibrillation during the monitoring period

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Region Gavleborg; 🇸🇪 Gävle, Sweden