Evaluation of 5 Days Holter and 30 Days Thumb-ECG for Detection of Atrial Fibrillation in Stroke Patients

Stroke Clinical Trial

— EHOT  

Official title:

Detection of Atrial Fibrillation, -Evaluation of 5 Days Holter and 30 Days Thumb-ECG for Detection of Atrial Fibrillation in Stroke Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02261766
• Other study ID #: EHOT001
• Status: Completed
• Phase: N/A
• First received: October 1, 2014
• Last updated: June 23, 2015
• Start date: August 2012
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: The National Committee on Health Research Ethics
• Study type: Interventional

Clinical Trial Summary

This study will compare the two methods 5 days holtermonitoring and 30 days thumb electrocardiogram for detection of atrial fibrillation in stroke patients

Description:

Patients with a newly stroke will be examined with both 5 day holter monitoring and 30 days thumb ECG at the same time. The detection rates of the two methods will be compared

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• stroke or TIA within the last 3 months verified by a CT or a MR scan or unequivocal symptoms and old infarcts visualised on CT or MR

• age 65 or above

• patients able to handle the thumb-ECG

• written informed consent

Exclusion Criteria:

• earlier diagnose of atrial fibrillation

• pacemaker or ICD device

• stroke induced by trauma, infection or surgery procedure

• carotid stenosis of more than 60%

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atrial Fibrillation
• Stroke

Intervention

Device:
• Holter monitoring and Thumb ECG
5 days holtermonitoring and 30 days 30 seconds twice daily thumb ECG recording

Locations

Country	Name	City	State
Denmark	Department of Neurology, Herlev Hospital	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atrial fibrillation detection rate on Thumb-ECG		1 month	No
Secondary	Atrial fibrillation detection rate on holtermonitoring		5 days	No
Secondary	Time to detection of atrial fibrillation on holter		5 days	No
Secondary	Time to detection af atrial fibrillation on thumb-ECG		30 days	No