StrokeNCT02155907
Atrial Fibrillation Detected by ELR and Holter Recording, a Comparison in Patients With Ischemic Stroke or TIA
An observational study of Stroke and Ischaemic Stroke, run by University of Aarhus at 1 site in Denmark.
Trial summary
Purpose 1. To validate 2 -day loop recording ( R.Test Evolution 4 ) to 2 -day Holter recording (gold standard) for the detection of atrial fibrillation of ≥ 30 seconds duration in a consecutive population of patients with stroke or transient ischemic attack (TIA). 2. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Stroke, Ischaemic Stroke, Atrial Fibrillation
- How many people
- 1,507 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2013to 31 Dec 2017
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stroke and TCI patients admitted to the Regional Hospital Holstebro
Who may be able to join
- Ischemic stroke or TIA within the last week. Sinus rhythm on the surface ECG. Age ≥ 60 years. Given written informed consent.
Who cannot join
- AF detected during hospitalization or earlier. Dementia or suspected non-compliance. Known cancer except c prostate with normal PSA, or basal cell carcinoma. Pacemaker or a defibrillator implanted
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Regional Hospital of Herning, Cardiovascular Research Unit, Medical Department
Herning, Jutland, 7400
About this study
Official title: Detection of Atrial Fibrillation in Patients With Recent Stroke or TIA: Validity of Automated Loop-recording (R.Test) Compared to Holter Recording and Predictive Value of Short Term Runs of Atrial Fibrillation and SVE for a New Stroke
Purpose
- To validate 2 -day loop recording ( R.Test Evolution 4 ) to 2 -day Holter recording (gold standard) for the detection of atrial fibrillation of ≥ 30 seconds duration in a consecutive population of patients with stroke or transient ischemic attack (TIA).
- To determine whether short run of atrial fibrillation (< 30s ) or the presence of many supraventricular extrasystoles detected on Holter recording, is associated with risk of re-stroke in a consecutive population of patients with stroke or TIA .
- To test whether a 7-day Loop Recording (R -test) detects more patients with atrial fibrillation than 2 days of Holter recording in a consecutive population of patients with stroke or TIA.
Read the detailed description
Project title:
Detection of atrial fibrillation in patients with recent stroke or TIA: Validity of automated loop-recording (Rtest) compared to Holter recording and predictive value of short runs of atrial fibrillation and an excess supraventricular extra systoles for a new stroke
Abstract:
Stroke constitutes a major health problem both nationally and globally. Each year 15 million people worldwide are attacked by stroke. In Denmark stroke hits 14.000 people a year and is the third leading cause of death. In this research project, we will examine the heart rate of more than 1,500 patients whom within 1 week has had a blood clot in the brain (ischemic stroke) or have had symptoms of a blood clot in the brain, which has dwindled within 24 hours (TIA). There are no clear international or national guidelines regarding the optimal way to detect atrial fibrillation in stroke and TIA patients, though atrial fibrillation is known to increase fivefold the risk of stroke. Holter recording with two days electrocardiogram is considered as the golden standard for investigation of heart rhythm disturbances and is offered at Department of Neurology in Holstebro, where we recruit patients. Holter recording is a resource-intensive procedure in data analysis. Project patients will be mounted with a 2- day Holter and Rtest for either 2 or 7 days. The Rtest is a loop recorder and a new device on the market that continuously monitor and opposite a Holter recorder, automatically analyses heart rhythm. The validity of the Rtest with regard to detect atrial fibrillation compared to Holter is unknown and is what we which to clarify. Additionally we use the 2-day Holter recordings to test whether short-term rhythm disorders as atrial fibrillation <30 seconds, and/or many extra heartbeats (supraventricular extra systoles) increases the risk of stroke recurrence. Patients will be followed in the Danish Stroke Register. If an increased risk is found, these gray area patients who are currently not offered anticoagulant therapy, may prove to have treatment indication. If the study shows that loop recording can replace Holter recording it will mean an economic gain. The study is expected to contribute substantial evidence for the future treatment of stroke and TIA patients.Stroke constitutes a major health problem both nationally and globally. Each year 15 million people worldwide are attacked by stroke. In Denmark stroke hits 14.000 people a year and is the third leading cause of death. In this research project, we will examine the heart rate of more than 1,500 patients whom within 1 week has had a blood clot in the brain (ischemic stroke) or have had symptoms of a blood clot in the brain, which has dwindled within 24 hours (TIA). There are no clear international or national guidelines regarding the optimal way to detect atrial fibrillation in stroke and TIA patients, though atrial fibrillation is known to increase fivefold the risk of stroke. Holter recording with two days electrocardiogram is considered as the golden standard for investigation of heart rhythm disturbances and is offered at Department of Neurology in Holstebro, where we recruit patients. Holter recording is a resource-intensive procedure in data analysis. Project patients will be mounted with a 2- day Holter and Rtest for either 2 or 7 days. The Rtest is a loop recorder and a new device on the market that continuously monitor and opposite a Holter recorder, automatically analyses heart rhythm. The validity of the Rtest with regard to detect atrial fibrillation compared to Holter is unknown and is what we which to clarify. Additionally we use the 2-day Holter recordings to test whether short-term rhythm disorders as atrial fibrillation <30 seconds, and/or many extra heartbeats (supraventricular extra systoles) increases the risk of stroke recurrence. Patients will be followed in the Danish Stroke Register. If an increased risk is found, these gray area patients who are currently not offered anticoagulant therapy, may prove to have treatment indication. If the study shows that loop recording can replace Holter recording it will mean an economic gain. The study is expected to contribute substantial evidence for the future treatment of stroke and TIA patients.
- Medical subject headings
- Stroke, Ischemic Stroke, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Rtest, Atrial fibrillation | Patients with ischemic stroke or TIA within the last week. Sinus rhythm on the surface ECG. Age ≥ 60 years. Given written informed consent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of restroke
Do short runs of atrial fibrillation < 30 seconds and/or many supraventricular extra systoles increase the risk of restroke?
Measured: 1 year
Secondary outcomes (1)
Validity of looprecordong (R. Test 4 Evolution) compared to Holter recording
Patients will be monitored with both an Holter recorder an a Rtest at the same time in respectively 2 and 2-7 days
Measured: 2-7 days pr. patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2014 (estimated)
- Study start1 Jun 2013
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,507 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Hospitalsenheden Vest
- Responsible party
- Sponsor
- Investigators
- Michala H Sejr, MD, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02155907
- Sponsor's protocol ID
- Rtest
- Status last verified
- Jun 2016
- First submitted
- 2 Jun 2014
- Last updated
- 7 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Sejr MH, May O, Damgaard D, Sandal BF, Nielsen JC. External continuous ECG versus loop recording for atrial fibrillation detection in patients who had a stroke. Heart. 2019 Jun;105(11):848-854. doi: 10.1136/heartjnl-2018-314186. Epub 2019 Mar 21.
PubMed 30898849
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Atrial Fibrillation in Patients With Recent Stroke or TIA: Validity of Automated Loop-recording (R.Test) Compared to Holter Recording and Predictive Value of Short Term Runs of Atrial Fibrillation and SVE for a New Stroke
- ClinicalTrials.gov ID
- NCT02155907
- Acronym / sponsor ID
- Rtest
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,507 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Hospitalsenheden Vest
- Study start
- 1 Jun 2013 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 4 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose
- To validate 2 -day loop recording ( R.Test Evolution 4 ) to 2 -day Holter recording (gold standard) for the detection of atrial fibrillation of ≥ 30 seconds duration in a consecutive population of patients with stroke or transient ischemic attack (TIA).
- To determine whether short run of atrial fibrillation (< 30s ) or the presence of many supraventricular extrasystoles detected on Holter recording, is associated with risk of re-stroke in a consecutive population of patients with stroke or TIA .
- To test whether a 7-day Loop Recording (R -test) detects more patients with atrial fibrillation than 2 days of Holter recording in a consecutive population of patients with stroke or TIA.
Detailed description
Project title:
Detection of atrial fibrillation in patients with recent stroke or TIA: Validity of automated loop-recording (Rtest) compared to Holter recording and predictive value of short runs of atrial fibrillation and an excess supraventricular extra systoles for a new stroke
Abstract:
Stroke constitutes a major health problem both nationally and globally. Each year 15 million people worldwide are attacked by stroke. In Denmark stroke hits 14.000 people a year and is the third leading cause of death. In this research project, we will examine the heart rate of more than 1,500 patients whom within 1 week has had a blood clot in the brain (ischemic stroke) or have had symptoms of a blood clot in the brain, which has dwindled within 24 hours (TIA). There are no clear international or national guidelines regarding the optimal way to detect atrial fibrillation in stroke and TIA patients, though atrial fibrillation is known to increase fivefold the risk of stroke. Holter recording with two days electrocardiogram is considered as the golden standard for investigation of heart rhythm disturbances and is offered at Department of Neurology in Holstebro, where we recruit patients. Holter recording is a resource-intensive procedure in data analysis. Project patients will be mounted with a 2- day Holter and Rtest for either 2 or 7 days. The Rtest is a loop recorder and a new device on the market that continuously monitor and opposite a Holter recorder, automatically analyses heart rhythm. The validity of the Rtest with regard to detect atrial fibrillation compared to Holter is unknown and is what we which to clarify. Additionally we use the 2-day Holter recordings to test whether short-term rhythm disorders as atrial fibrillation <30 seconds, and/or many extra heartbeats (supraventricular extra systoles) increases the risk of stroke recurrence. Patients will be followed in the Danish Stroke Register. If an increased risk is found, these gray area patients who are currently not offered anticoagulant therapy, may prove to have treatment indication. If the study shows that loop recording can replace Holter recording it will mean an economic gain. The study is expected to contribute substantial evidence for the future treatment of stroke and TIA patients.Stroke constitutes a major health problem both nationally and globally. Each year 15 million people worldwide are attacked by stroke. In Denmark stroke hits 14.000 people a year and is the third leading cause of death. In this research project, we will examine the heart rate of more than 1,500 patients whom within 1 week has had a blood clot in the brain (ischemic stroke) or have had symptoms of a blood clot in the brain, which has dwindled within 24 hours (TIA). There are no clear international or national guidelines regarding the optimal way to detect atrial fibrillation in stroke and TIA patients, though atrial fibrillation is known to increase fivefold the risk of stroke. Holter recording with two days electrocardiogram is considered as the golden standard for investigation of heart rhythm disturbances and is offered at Department of Neurology in Holstebro, where we recruit patients. Holter recording is a resource-intensive procedure in data analysis. Project patients will be mounted with a 2- day Holter and Rtest for either 2 or 7 days. The Rtest is a loop recorder and a new device on the market that continuously monitor and opposite a Holter recorder, automatically analyses heart rhythm. The validity of the Rtest with regard to detect atrial fibrillation compared to Holter is unknown and is what we which to clarify. Additionally we use the 2-day Holter recordings to test whether short-term rhythm disorders as atrial fibrillation <30 seconds, and/or many extra heartbeats (supraventricular extra systoles) increases the risk of stroke recurrence. Patients will be followed in the Danish Stroke Register. If an increased risk is found, these gray area patients who are currently not offered anticoagulant therapy, may prove to have treatment indication. If the study shows that loop recording can replace Holter recording it will mean an economic gain. The study is expected to contribute substantial evidence for the future treatment of stroke and TIA patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rtest, Atrial fibrillation | – | –Patients with ischemic stroke or TIA within the last week. Sinus rhythm on the surface ECG. Age ≥ 60 years. Given written informed consent |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke and TCI patients admitted to the Regional Hospital Holstebro
Key inclusion criteria (1 listed)
- Ischemic stroke or TIA within the last week. Sinus rhythm on the surface ECG. Age ≥ 60 years. Given written informed consent.
Key exclusion criteria (1 listed)
- AF detected during hospitalization or earlier. Dementia or suspected non-compliance. Known cancer except c prostate with normal PSA, or basal cell carcinoma. Pacemaker or a defibrillator implanted
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of restroke
Time frame: 1 year
Do short runs of atrial fibrillation < 30 seconds and/or many supraventricular extra systoles increase the risk of restroke?
1 secondary outcome
Validity of looprecordong (R. Test 4 Evolution) compared to Holter recording
Time frame: 2-7 days pr. patient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2018.
- Derived from this study: PubMed 30898849Sejr MH, May O, Damgaard D, Sandal BF, Nielsen JC. External continuous ECG versus loop recording for atrial fibrillation detection in patients who had a stroke. Heart. 2019 Jun;105(11):848-854. doi: 10.1136/heartjnl-2018-314186. Epub 2019 Mar 21.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michala H Sejr, MD principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Ischaemic Stroke, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of restroke (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02155907, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2018.