Early Detection Of Atrial Fibrillation In Patients With Transient Ischemic Attack (NOTICE)
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|ClinicalTrials.gov Identifier: NCT02011256|
Recruitment Status : Active, not recruiting
First Posted : December 13, 2013
Last Update Posted : March 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Transient Ischemic Attack Atrial Fibrillation||Device: Implantable loop-recorder||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Early Detection Of Atrial Fibrillation In Patients With Transient Ischemic Attack - A Prospective Study|
|Actual Study Start Date :||September 2013|
|Estimated Primary Completion Date :||November 2017|
|Estimated Study Completion Date :||November 2017|
|Experimental: Implantable loop-recorder||
Device: Implantable loop-recorder
All patients not diagnosed with atrial fibrillation with regular ECG or 72-hour Holter-monitoring will receive an ILR for 3 years.
Other Name: Reveal XT, Medtronic Inc.
- Percentage of patients with TIA diagnosed with atrial fibrillation [ Time Frame: 1 year ]All TIA-patients with no prior history of atrial fibrillation (AFLI) will be monitored for AFLI with 1) regular 12-lead ECG 2) 72-h Holter-monitoring and 3) implantable loop-recorder (ILR). If AFLI is diagnosed, then the patients will not receive further monitoring ie. not all patients will get Holter or ILR.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02011256
|Department of Cardiology, Odense Universityhospital|
|Odense, Funen, Denmark, 5000|
|Principal Investigator:||Kenneth Pedersen, MD||University of Southern Denmark|