Back to resultsEvaluation of 5 Days Holter and 30 Days Thumb-ECG for Detection of Atrial Fibrillation in Stroke Patients (EHOT)
Primary Purpose
Atrial Fibrillation, Stroke
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Holter monitoring and Thumb ECG
Sponsored by
About this trial
This is an interventional prevention trial for Atrial Fibrillation
Eligibility Criteria
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%
Sites / Locations
- Department of Neurology, Herlev Hospital
Outcomes
Primary Outcome Measures
Atrial fibrillation detection rate on Thumb-ECG
Secondary Outcome Measures
Atrial fibrillation detection rate on holtermonitoring
Time to detection of atrial fibrillation on holter
Time to detection af atrial fibrillation on thumb-ECG
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02261766
Brief Title
Evaluation of 5 Days Holter and 30 Days Thumb-ECG for Detection of Atrial Fibrillation in Stroke Patients
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Herlev Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will compare the two methods 5 days holtermonitoring and 30 days thumb electrocardiogram for detection of atrial fibrillation in stroke patients
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Stroke
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Holter monitoring and Thumb ECG
Intervention Description
5 days holtermonitoring and 30 days 30 seconds twice daily thumb ECG recording
Primary Outcome Measure Information:
Title
Atrial fibrillation detection rate on Thumb-ECG
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Atrial fibrillation detection rate on holtermonitoring
Time Frame
5 days
Title
Time to detection of atrial fibrillation on holter
Time Frame
5 days
Title
Time to detection af atrial fibrillation on thumb-ECG
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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%
Facility Information:
Facility Name
Department of Neurology, Herlev Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
27694312
Citation
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.
Results Reference
derived
Learn more about this trial
Evaluation of 5 Days Holter and 30 Days Thumb-ECG for Detection of Atrial Fibrillation in Stroke Patients
We'll reach out to this number within 24 hrs