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

June 23, 2015 updated by: Karsten Overgaard, Herlev Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Device: Holter monitoring and Thumb ECG

Detailed 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

Study Type

Interventional

Enrollment (Actual)

100

Phase

Not Applicable

Contacts and Locations

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

Study Locations

Denmark
- - Herlev, Denmark, 2730
    - Department of Neurology, Herlev Hospital

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

65 years and older (Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 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

Primary Purpose: Prevention
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Atrial fibrillation detection rate on Thumb-ECG Time Frame: 1 month	1 month

Secondary Outcome Measures

Outcome Measure	Time Frame
Atrial fibrillation detection rate on holtermonitoring Time Frame: 5 days	5 days
Time to detection of atrial fibrillation on holter Time Frame: 5 days	5 days
Time to detection af atrial fibrillation on thumb-ECG Time Frame: 30 days	30 days

Collaborators and Investigators

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

Sponsor

Herlev Hospital

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

Poulsen MB, Binici Z, Dominguez H, Soja AM, Kruuse C, Hornnes AH, Rasmussen RS, Overgaard K. Performance of short ECG recordings twice daily to detect paroxysmal atrial fibrillation in stroke and transient ischemic attack patients. Int J Stroke. 2017 Feb;12(2):192-196. doi: 10.1177/1747493016669883. Epub 2016 Sep 30.

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

August 1, 2012

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

October 1, 2014

First Submitted That Met QC Criteria

October 7, 2014

First Posted (Estimate)

October 10, 2014

Study Record Updates

Last Update Posted (Estimate)

June 24, 2015

Last Update Submitted That Met QC Criteria

June 23, 2015

Last Verified