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Thumb ECG IncidenT Atrial fibrillatioN in Diabetes Mellitus (TITAN-DM)

R

Region Gävleborg

Status

Unknown

Conditions

Atrial Fibrillation
Diabetes Mellitus

Treatments

Diagnostic Test: Coala Heart Monitor Pro

Study type

Observational

Funder types

Other

Identifiers

NCT05174390
202103323

Details and patient eligibility

About

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.

Full 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.

Enrollment

600 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Lise-Lotte Sundgren, MSc; Peter Magnusson, MD PhD

Data sourced from clinicaltrials.gov

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