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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Southern Denmark
Sponsor:
Collaborator:
Region Southern Denmark
Information provided by (Responsible Party):
Kenneth Pedersen, University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT02011256
First received: December 9, 2013
Last updated: December 13, 2013
Last verified: December 2013
  Purpose

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 Intervention
Transient Ischemic Attack
Atrial Fibrillation
Device: Implantable loop-recorder

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Early Detection Of Atrial Fibrillation In Patients With Transient Ischemic Attack - A Prospective Study

Resource links provided by NLM:


Further study details as provided by University of Southern Denmark:

Primary Outcome Measures:
  • Percentage of patients with TIA diagnosed with atrial fibrillation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 150
Study Start Date: September 2013
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02011256

Contacts
Contact: Kenneth Pedersen, MD 004540951145 notice@rsyd.dk
Contact: Axel Brandes

Locations
Denmark
Department of Cardiology, Odense Universityhospital Recruiting
Odense, Funen, Denmark, 5000
Contact: Kenneth Pedersen, MD    004540951145    notice@rsyd.dk   
Contact: Axel Brandes, MD, DMSc       Axel.Brandes@rsyd.dk   
Principal Investigator: Kenneth Pedersen, MD         
Sponsors and Collaborators
University of Southern Denmark
Region Southern Denmark
Investigators
Principal Investigator: Kenneth Pedersen, MD University of Southern Denmark
  More Information

No publications provided

Responsible Party: Kenneth Pedersen, MD, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT02011256     History of Changes
Other Study ID Numbers: S-20130027
Study First Received: December 9, 2013
Last Updated: December 13, 2013
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Health and Medicines Authority

Keywords provided by University of Southern Denmark:
Transient Ischemic Attack
Atrial Fibrillation
NOTICE
Implantable loop-recorder
Holter-monitoring

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

ClinicalTrials.gov processed this record on September 18, 2014