- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02011256
Early Detection Of Atrial Fibrillation In Patients With Transient Ischemic Attack (NOTICE)
Early Detection Of Atrial Fibrillation In Patients With Transient Ischemic Attack - A Prospective Study
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Funen
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Odense, Funen, Denmark, 5000
- Department of Cardiology, Odense Universityhospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Implantable loop-recorder
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All patients not diagnosed with atrial fibrillation with regular ECG or 72-hour Holter-monitoring will receive an ILR for 3 years.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kenneth Pedersen, MD, University of Southern Denmark
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- S-20130027
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Ablacon, Inc.RecruitingAtrial Fibrillation | Arrhythmias, Cardiac | Arrhythmia | Atrial Flutter | Atrial Fibrillation, Persistent | Atrial Tachycardia | Atrial Arrhythmia | Atrial Fibrillation Paroxysmal | Atrial Fibrillation, Paroxysmal or PersistentUnited States, Belgium, Netherlands, Czechia
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Maastricht University Medical CenterRWTH Aachen UniversityUnknownAtrial Fibrillation (Paroxysmal) | Atrial Fibrillation Recurrent | Atrial Fibrillation Common Gene VariantsNetherlands
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Adagio MedicalRecruitingAtrial Fibrillation | Atrial Flutter | Paroxysmal Atrial Fibrillation | Persistent Atrial FibrillationNetherlands, Germany, Belgium
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Fundació Institut de Recerca de l'Hospital de la...RecruitingAtrial Arrhythmia | Atrial Fibrillation and Flutter | Atrial Fibrillation RecurrentSpain
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St. George's Hospital, LondonRecruitingAtrial Fibrillation | Atrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Atrial ArrhythmiaUnited Kingdom
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R-PharmFSBI "National Medical Research Center of Cardiology named after academician...CompletedAtrial Flutter | Paroxysmal Atrial Fibrillation | Persistent Atrial FibrillationRussian Federation
Clinical Trials on Implantable loop-recorder
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Leonardo Calò, MDNot yet recruiting
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Fundación Instituto de Estudios de Ciencias de...Instituto de Salud Carlos III; Spanish Society of Cardiology; Sanidad de Castilla...Active, not recruitingMyocardial Infarction | Death, Sudden | Ventricular Tachycardia | Implantable Defibrillator User | Myocardial DysfunctionSpain
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Canadian Institutes of Health Research (CIHR)Vanderbilt UniversityCompletedHeart Block | Syncope | Conduction Disorder of the HeartUnited Kingdom, Canada, United States, Malaysia, Japan
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Barts & The London NHS TrustCompleted
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University of PennsylvaniaMedtronicCompletedAtrial FibrillationUnited States
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Central Hospital, Nancy, FranceNot yet recruitingMyocardial Infarction | Ventricular Fibrillation | Ventricular Tachycardia | Sudden Cardiac DeathFrance
-
Meshalkin Research Institute of Pathology of CirculationUnknownAtrial FibrillationRussian Federation
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Medtronic Bakken Research CenterMedtronicCompleted
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Seoul National University HospitalSamsung Medical Center; Asan Medical Center; Seoul National University Bundang... and other collaboratorsActive, not recruitingAtrial Fibrillation, PersistentKorea, Republic of
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Medical University of GrazMedtronicUnknownHypertension | Diabetes | Atrial Fibrillation | Chronic Heart Failure | Vascular DiseaseAustria