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Thumb ECG IncidenT Atrial fibrillatioN in Diabetes Mellitus

NCT ID: NCT05174390

Last Updated: 2021-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-20

Study Completion Date

2022-06-20

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus Atrial Fibrillation

Keywords

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atrial fibrillation diabetes mellitus thumb-ECG

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Coala Heart Monitor Pro

thumb- and chest-ECG

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Gävleborg

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Region Gavleborg

Gävle, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Lise-Lotte Sundgren, MSc

Role: CONTACT

Phone: +4626154000

Email: [email protected]

Peter Magnusson, MD PhD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Peter Magnusson, M.D. Ph.D.

Role: primary

Lise-Lotte Sundgren, MSc

Role: backup

References

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Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomstrom-Lundqvist C, Boriani G, Castella M, Dan GA, Dilaveris PE, Fauchier L, Filippatos G, Kalman JM, La Meir M, Lane DA, Lebeau JP, Lettino M, Lip GYH, Pinto FJ, Thomas GN, Valgimigli M, Van Gelder IC, Van Putte BP, Watkins CL; ESC Scientific Document Group. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2021 Feb 1;42(5):373-498. doi: 10.1093/eurheartj/ehaa612. No abstract available.

Reference Type BACKGROUND
PMID: 32860505 (View on PubMed)

Magnusson P, Lyren A, Mattsson G. Patient-reported feasibility of chest and thumb ECG after cryptogenic stroke in Sweden: an observational study. BMJ Open. 2020 Oct 28;10(10):e037360. doi: 10.1136/bmjopen-2020-037360.

Reference Type BACKGROUND
PMID: 33115891 (View on PubMed)

Other Identifiers

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202103323

Identifier Type: -

Identifier Source: org_study_id