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

NCT02155907 | Completed

• 1 other identifier: Rtest
• Study Type: observational
• Target: 1,507
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose

1. 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. 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. 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.

Conditions

Stroke; Ischaemic Stroke; Atrial Fibrillation; Supra Ventricular Extra Systoles

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Validity of looprecordong (R. Test 4 Evolution) compared to Holter recording

  2-7 days pr. patient

Study Arms (1)

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

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stroke and TCI patients admitted to the Regional Hospital Holstebro

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Hospitalsenheden Vest: collaborator

Study Sites (1)

Regional Hospital of Herning, Cardiovascular Research Unit, Medical Department

Herning, Jutland, 7400, Denmark

Location

Related Publications (1)

• 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.

  PMID: 30898849 DERIVED

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michala H Sejr, MD

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2014
• First Posted: June 4, 2014
• Study Start: June 1, 2013
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: May 7, 2018

Record last verified: 2016-06

Locations

DK (1)