Early Detection Of Atrial Fibrillation In Patients With Transient Ischemic Attack (NOTICE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02011256
Recruitment Status : Active, not recruiting
First Posted : December 13, 2013
Last Update Posted : March 9, 2017
Region of Southern Denmark
Information provided by (Responsible Party):
Kenneth Pedersen, University of Southern Denmark

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Transient Ischemic Attack Atrial Fibrillation Device: Implantable loop-recorder Not Applicable

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02011256

Department of Cardiology, Odense Universityhospital
Odense, Funen, Denmark, 5000
Sponsors and Collaborators
University of Southern Denmark
Region of Southern Denmark
Principal Investigator: Kenneth Pedersen, MD University of Southern Denmark

Responsible Party: Kenneth Pedersen, MD, University of Southern Denmark Identifier: NCT02011256     History of Changes
Other Study ID Numbers: S-20130027
First Posted: December 13, 2013    Key Record Dates
Last Update Posted: March 9, 2017
Last Verified: March 2017

Keywords provided by Kenneth Pedersen, University of Southern Denmark:
Transient Ischemic Attack
Atrial Fibrillation
Implantable loop-recorder

Additional relevant MeSH terms:
Atrial Fibrillation
Ischemic Attack, Transient
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases