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

December 13, 2021 updated by: Region Gävleborg
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

61 years and older (Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Unselected patients with diabetes type 1 or type 2 at an age of 65 years and above.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with the diagnosis of atrial fibrillation
Time Frame: 90 days
Incidence of atrial fibrillation during the monitoring period
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-reported symptoms (descriptive category variables) of atrial fibrillation using a questionnaire in a digital application
Time Frame: 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.
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Gävleborg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2021

Primary Completion (Anticipated)

April 20, 2022

Study Completion (Anticipated)

June 20, 2022

Study Registration Dates

First Submitted

November 30, 2021

First Submitted That Met QC Criteria

December 13, 2021

First Posted (Actual)

December 30, 2021

Study Record Updates

Last Update Posted (Actual)

December 30, 2021

Last Update Submitted That Met QC Criteria

December 13, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202103323

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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