Clinical trial NCT02155907: Atrial Fibrillation Detected by ELR and Holter Recording, a Comparison in Patients With Ischemic Stroke or TIA
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Ischaemic Stroke
Atrial Fibrillation
Supra Ventricular Extra Systoles
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Hospitalsenheden Vest
First posted: 2014-06-04
Enrollment: 1507
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stroke and TCI patients admitted to the Regional Hospital Holstebro

Brief 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. 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 .
3. 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.

Eligibility criteria: Inclusion Criteria:

* Ischemic stroke or TIA within the last week. Sinus rhythm on the surface ECG. Age ≥ 60 years. Given written informed consent.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Incidence of restroke
timeFrame: 1 year
Secondary outcomes:
measure: Validity of looprecordong (R. Test 4 Evolution) compared to Holter recording
timeFrame: 2-7 days pr. patient
Other outcomes:
Locations:
city: Herning
country: Denmark
facility: Regional Hospital of Herning, Cardiovascular Research Unit, Medical Department
state: Jutland
Study officials:
affiliation: University of Aarhus
name: Michala H Sejr, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.