Atrial Fibrillation, Diabetes Mellitus
Conditions
Keywords
atrial fibrillation, diabetes mellitus, thumb-ECG
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.
Interventions
DIAGNOSTIC_TESTCoala Heart Monitor Pro
thumb- and chest-ECG
Sponsors
Region Gävleborg
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with the diagnosis of atrial fibrillation | 90 days | Incidence of atrial fibrillation during the monitoring period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Sweden
Contacts
Primary ContactLise-Lotte Sundgren, MSc
Backup ContactPeter Magnusson, MD PhD
Outcome results
None listed