NCT05174390|Unknown
Thumb ECG IncidenT Atrial fibrillatioN in Diabetes Mellitus
TITAN-DM
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TITAN-DM
Sponsor study identifier
observational
600
1 country
1
Study Start
September 20, 2021
Actual (reported)Primary Completion
April 20, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 20, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 20, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 20, 2021
Actual (reported)November 30, 2021
Actual (reported)December 30, 2021
Actual (reported)April 20, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 20, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Number of participants with the diagnosis of atrial fibrillation
Incidence of atrial fibrillation during the monitoring period
90 days
Patient-reported symptoms (descriptive category variables) of atrial fibrillation using a questionnaire in a digital application
90 days
thumb- and chest-ECG
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Unselected patients with diabetes type 1 or type 2 at an age of 65 years and above.
Region Gavleborg
Gävle, 80324, Sweden
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.
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.
First Submitted
November 30, 2021
First Posted
December 30, 2021
Study Start
September 20, 2021
Actual (reported)Primary Completion
April 20, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Atrial Fibrillation Symptoms and Pain Sensitization
Contact the study team to confirm eligibility.
Study Completion
June 20, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 30, 2021
Record last verified: 2021-11
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Source: ClinicalTrials.gov.
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