NCT05174390

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 30, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2022

Completed
Last Updated

December 30, 2021

Status Verified

November 1, 2021

Enrollment Period

7 months

First QC Date

November 30, 2021

Last Update Submit

December 13, 2021

Conditions

Diabetes MellitusAtrial Fibrillation

Keywords

atrial fibrillationdiabetes mellitusthumb-ECG

Outcome Measures

Primary Outcomes (1)

  • Number of participants with the diagnosis of atrial fibrillation

    Incidence of atrial fibrillation during the monitoring period

    90 days

Secondary Outcomes (1)

  • Patient-reported symptoms (descriptive category variables) of atrial fibrillation using a questionnaire in a digital application

    90 days

Interventions

Coala Heart Monitor ProDIAGNOSTIC_TEST

thumb- and chest-ECG

Eligibility Criteria

Age65 Years+
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Age 65 years and above
  • Diabetes mellitus (both type 1 and type 2)

You may not qualify if:

  • Treatment with anticoagulation (Eliquis, Lixiana, Pradaxa, Xarelto, Waran)
  • Pacemaker, implantable cardioverter defibrillator, insertable cardiac monitor
  • Not able to participate in 90 days follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Region Gavleborg

Gävle, 80324, Sweden

RECRUITING

Related Publications (2)

  • 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.

    PMID: 32860505BACKGROUND

  • 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.

    PMID: 33115891BACKGROUND

MeSH Terms

Conditions

Diabetes MellitusAtrial Fibrillation

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Lise-Lotte Sundgren, MSc

CONTACT

+4626154000lise-lotte.sundgren@regiongavleborg.se

Peter Magnusson, MD PhD

CONTACT

peter.magnusson@regiongavleborg.se

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2021

First Posted

December 30, 2021

Study Start

September 20, 2021

Primary Completion

April 20, 2022

Study Completion

June 20, 2022

Last Updated

December 30, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)