Thumb ECG IncidenT Atrial fibrillatioN in Diabetes Mellitus

Atrial Fibrillation Clinical Trial

— TITAN-DM  

Official title:

Thumb ECG IncidenT Atrial fibrillatioN in Diabetes Mellitus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05174390
• Other study ID #: 202103323
• Status: Recruiting
• Start date: September 20, 2021
• Est. completion date: June 20, 2022

Study information

• Verified date: November 2021
• Source: Region Gävleborg
• Contact: Lise-Lotte Sundgren, MSc
• Phone: +4626154000
• Email: lise-lotte.sundgren[@]regiongavleborg.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: June 20, 2022
• Est. primary completion date: April 20, 2022
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Diabetes Mellitus

Intervention

Diagnostic Test:
• Coala Heart Monitor Pro
thumb- and chest-ECG

Locations

Country	Name	City	State
Sweden	Region Gavleborg	Gävle

Sponsors (1)

Lead Sponsor	Collaborator
Region Gävleborg

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomström-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. Erratum in: Eur Heart J. 2021 Feb 1;42(5):507. Eur Heart J. 2021 Feb 1;42(5):546-547. Erratum in: Eur Heart J. 2021 Oct 21;42(40):4194. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with the diagnosis of atrial fibrillation	Incidence of atrial fibrillation during the monitoring period	90 days
Secondary	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