Atrial Fibrillation Detected by ELR and Holter Recording, a Comparison in Patients With Ischemic Stroke or TIA

Stroke Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02155907
• Other study ID #: Rtest
• Status: Completed
• Start date: June 1, 2013
• Est. completion date: December 31, 2017

Study information

• Verified date: June 2016
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1507
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cerebral Infarction
• Ischaemic Stroke
• Ischemia
• Stroke
• Supra Ventricular Extra Systoles
• Ventricular Premature Complexes

Locations

Country	Name	City	State
Denmark	Regional Hospital of Herning, Cardiovascular Research Unit, Medical Department	Herning	Jutland

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Hospitalsenheden Vest

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of restroke	Do short runs of atrial fibrillation < 30 seconds and/or many supraventricular extra systoles increase the risk of restroke?	1 year
Secondary	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	2-7 days pr. patient