Early Detection Of Atrial Fibrillation In Patients With Transient Ischemic Attack (NOTICE)
Primary Purpose
Transient Ischemic Attack, Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Implantable loop-recorder
Sponsored by
About this trial
This is an interventional diagnostic trial for Transient Ischemic Attack focused on measuring Transient Ischemic Attack, Atrial Fibrillation, NOTICE, Implantable loop-recorder, Holter-monitoring
Eligibility Criteria
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
Sites / Locations
- Department of Cardiology, Odense Universityhospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Implantable loop-recorder
Arm Description
Outcomes
Primary Outcome Measures
Percentage of patients with TIA diagnosed with atrial fibrillation
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02011256
First Posted
December 9, 2013
Last Updated
April 15, 2019
Sponsor
University of Southern Denmark
Collaborators
Region of Southern Denmark
1. Study Identification
Unique Protocol Identification Number
NCT02011256
Brief Title
Early Detection Of Atrial Fibrillation In Patients With Transient Ischemic Attack
Acronym
NOTICE
Official Title
Early Detection Of Atrial Fibrillation In Patients With Transient Ischemic Attack - A Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
September 2013 (Actual)
Primary Completion Date
February 2019 (Actual)
Study Completion Date
March 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern Denmark
Collaborators
Region of Southern Denmark
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transient Ischemic Attack, Atrial Fibrillation
Keywords
Transient Ischemic Attack, Atrial Fibrillation, NOTICE, Implantable loop-recorder, Holter-monitoring
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Implantable loop-recorder
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Implantable loop-recorder
Other Intervention Name(s)
Reveal XT, Medtronic Inc.
Intervention Description
All patients not diagnosed with atrial fibrillation with regular ECG or 72-hour Holter-monitoring will receive an ILR for 3 years.
Primary Outcome Measure Information:
Title
Percentage of patients with TIA diagnosed with atrial fibrillation
Description
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.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Pedersen, MD
Organizational Affiliation
University of Southern Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiology, Odense Universityhospital
City
Odense
State/Province
Funen
ZIP/Postal Code
5000
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Early Detection Of Atrial Fibrillation In Patients With Transient Ischemic Attack
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