Evaluation of 5 Days Holter and 30 Days Thumb-ECG for Detection of Atrial Fibrillation in Stroke Patients
EHOT
Detection of Atrial Fibrillation, -Evaluation of 5 Days Holter and 30 Days Thumb-ECG for Detection of Atrial Fibrillation in Stroke Patients
1 other identifier
interventional
100
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable atrial-fibrillation
Started Aug 2012
Typical duration for not_applicable atrial-fibrillation
1 active site
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
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 1, 2014
CompletedFirst Posted
Study publicly available on registry
October 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedJune 24, 2015
June 1, 2015
2.5 years
October 1, 2014
June 23, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Atrial fibrillation detection rate on Thumb-ECG
1 month
Secondary Outcomes (3)
Atrial fibrillation detection rate on holtermonitoring
5 days
Time to detection of atrial fibrillation on holter
5 days
Time to detection af atrial fibrillation on thumb-ECG
30 days
Interventions
5 days holtermonitoring and 30 days 30 seconds twice daily thumb ECG recording
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- earlier diagnose of atrial fibrillation
- pacemaker or ICD device
- stroke induced by trauma, infection or surgery procedure
- carotid stenosis of more than 60%
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Herlev Hospitallead
Study Sites (1)
Department of Neurology, Herlev Hospital
Herlev, 2730, Denmark
Related Publications (1)
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.
PMID: 27694312DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor
Study Record Dates
First Submitted
October 1, 2014
First Posted
October 10, 2014
Study Start
August 1, 2012
Primary Completion
February 1, 2015
Study Completion
June 1, 2015
Last Updated
June 24, 2015
Record last verified: 2015-06