This trial is active, not recruiting.

Conditions transient ischemic attack, atrial fibrillation
Treatment implantable loop-recorder
Sponsor University of Southern Denmark
Collaborator Region of Southern Denmark
Start date September 2013
End date December 2016
Trial size 150 participants
Trial identifier NCT02011256, S-20130027


The purpose of this study is to determine the frequency of atrial fibrillation in patients with transient ischemic attack (TIA). Patients suffering TIA will have their heart rhythm extensively monitored with 72-hour Holter-monitoring and an implantable loop-recorder. Furthermore, the patients will be examined with echocardiography, coronary calcium-score and biomarkers with the purpose to predict which subjects at risk for developing atrial fibrillation.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic
implantable loop-recorder Reveal XT, Medtronic Inc.
All patients not diagnosed with atrial fibrillation with regular ECG or 72-hour Holter-monitoring will receive an ILR for 3 years.

Primary Outcomes

Percentage of patients with TIA diagnosed with atrial fibrillation
time frame: 1 year

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - Diagnosed with TIA by a board certified neurologist - Written consent - Residents of Funen, Denmark or surrounding islands Exclusion Criteria: - Prior stroke - Known atrial fibrillation - Known contraindication for anticoagulant therapy - Patients already in anticoagulant therapy - Patients with estimated short life expectancy - Pregnancy - Prior TIA with known etiology

Additional Information

Official title Early Detection Of Atrial Fibrillation In Patients With Transient Ischemic Attack - A Prospective Study
Principal investigator Kenneth Pedersen, MD
Description Stroke is a leading cause of death and the survivors are often left with severe disability. Transient ischemic attack (TIA) is an episode of neurological dysfunction, but unlike stroke, the neurological deficits resolve completely within 24 hours. TIA and stroke share the same common underlying cause, and patients with a TIA are at high risk for developing a subsequent stroke. Atrial fibrillation (AF) is the most common cardiac arrhythmia and is recognized as the cause of around 25% of all strokes. The prevalence of AF rises with age, and it is estimated, that approximately 5-10% of all subjects over the age of 80 years has either persistent or paroxysmal AF. Regardless of the AF subtype the risk for stroke is the same, and oral anticoagulation therapy is recognized as a superior treatment of AF related stroke/TIA. The goal of this project is to extend the normal workup of patients with TIA with a thorough heart monitoring program. This includes 72-hours ambulatory electrocardiogram and insertion of an implantable loop recorder (ILR). The ILR is small device implanted in the subcutaneous tissue in the left thoracic region. The device continuously monitors for arrhythmias in a period up to 3 years. The 150 patients enrolled will also receive an ultrasound examination of the heart and arteries of the neck and a computed tomography scan of the heart. Lastly, biomarkers with known or suspected association with stroke and AF will be measured. The primary goal of the study is to determine, whether or not an extended heart monitoring program with an ILR will identify more patients with AF as the underlying cause of TIA. This can have enormous advantages for the patient, because the treatment with oral anticoagulation therapy reduces the risk of subsequent stroke by approximately 40% compared to conventional antiplatelet therapy. Secondly, the study means to identify patients at high risk for developing AF assessed with ultrasound, computed tomography and novel biomarkers.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by University of Southern Denmark.