Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Atrial Fibrillation in Cryptogenic Stroke and TIA (NOR-FIB)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02937077
Recruitment Status : Recruiting
First Posted : October 18, 2016
Last Update Posted : June 13, 2018
Sponsor:
Collaborators:
Ostfold Hospital Trust
Haukeland University Hospital
Rigshospitalet, Denmark
Bispebjerg Hospital
St. Olavs Hospital
The Hospital of Vestfold
Sykehuset Telemark
Herlev Hospital
Nordlandssykehuset HF
Vestre Viken Hospital Trust
Helse Stavanger HF
Molde Hospital
Drammen sykehus
Diakonhjemmet Hospital
Information provided by (Responsible Party):
Anne Hege Aamodt, Oslo University Hospital

Brief Summary:

Background:

Different studies with real-life data and randomized controlled trials have shown a detection rate of paroxysmal atrial fibrillation (AF) of 10-20% in patients with cryptogenic stroke using insertable continuous cardiac monitoring for 6 months. More studies are needed, however, to identify factors which can be used to select the patients where the possibility of detecting AF with prolonged rhythm monitoring is highest, to evaluate the best duration of rhythm monitoring, to determine the optimal definition of short-term AF that warrants intervention and to evaluate whether intervention results in improved clinical outcomes.

Methods: The NOR-FIB study is a multi-centre prospective observational trial, designed to evaluate detection of AF in cryptogenic stroke and transient ischemic attack (TIA). Patients admitted with cryptogenic stroke or TIA in stroke units in the Nordic countries, aged 18-80 years are included and have the Reveal LINQ® Insertable cardiac monitor system implanted for 12 months for the purpose of AF detection. Biomarkers that may identify patients, who could derive the most clinical benefit from the detection of AF by prolonged monitoring, are being studied.

Conclusion: This NOR-FIB study will increase our knowledge regarding the occurrence of AF in patients with cryptogenic stroke and TIA that potentially can improve secondary prevention. The study will provide information on biomarkers that may be used to select cryptogenic TIA and stroke patients for long-term monitoring as well as information on the significance of short-term AF and optimal duration of cardiac rhythm monitoring.


Condition or disease Intervention/treatment
Atrial Fibrillation Ischemic Stroke TIA Device: Medtronic Reveal LINQ

Layout table for study information
Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Nordic Atrial Fibrillation and Stroke Study
Actual Study Start Date : December 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Atrial fibrillation detection rate [ Time Frame: within 6 months ]

Secondary Outcome Measures :
  1. AF detection rate [ Time Frame: within 12 months ]
  2. Levels of miRNAs related to atrial fibrillation [ Time Frame: 12 months ]
  3. Levels of NT-proBNP [ Time Frame: baseline and 12 months ]
  4. Levels of Troponin-T [ Time Frame: baseline and 12 months ]
  5. Levels of inflammation biomarkers [ Time Frame: baseline and 12 months ]
  6. Prestroke/pre-TIA CHA2DS2-VASc score [ Time Frame: baseline ]
  7. Incidence of recurrent stroke or TIA - percentage of stroke/TIA within 12 9. Incidence of recurrent stroke or TIA - percentage of stroke/TIA [ Time Frame: 12 months ]
  8. Use of oral anticoagulation - percentage of patients who are using OAC drugs [ Time Frame: 12 months ]
  9. Use of antiarrhythmic drugs - percentage of patients who are using antiarrhythmic drugs [ Time Frame: 12 month ]
  10. Health Outcome as Evaluated by an EQ-5D Questionnaire - EQ-5D quality of life score [ Time Frame: 12 months ]

Biospecimen Retention:   Samples With DNA
blood samples


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted to stroke units with cryptogenic ischemic stroke or TIA
Criteria

Inclusion Criteria:

  1. Cryptogenic ischemic stroke patients or symptomatic TIA < 21 days from symptom start.
  2. A stroke/TIA is considered to be cryptogenic if no cause can be determined despite an extensive workup according to the standard protocol of the participating center. Before inclusion to the study, the following tests are required as standard tests to establish the diagnosis of cryptogenic stroke or TIA:

    1. Brain MRI or CT†
    2. 12-lead ECG for AF detection
    3. 24-h ECG monitoring for AF detection and premature atrial complex analysis (e.g. Holter)
    4. TEE (transesophageal echocardiography) highly recommended or TTE (transthoracic echocardiography)
    5. Colour Duplex ultrasound examination of the pre-cerebral arteries
    6. CTA or MRA of head and neck to rule out other causes of stroke pathologies
  3. Age 18 to 80 at onset of TIA/stroke
  4. A participation consent form signed by the patient or a legally authorized representative.

    • TIA cases with acute non-lacunar infarct on Diffusion Weighted Imaging are included as TIA events.

Exclusion Criteria:

  1. Known etiology of TIA or stroke.
  2. TIA without documented cerebral ischemia on Diffusion Weighed Imaging.
  3. Untreated hyperthyroidism
  4. Myocardial infarction less than 1 month prior to the stroke or TIA.
  5. Coronary bypass grafting less than 1 month prior to the stroke or TIA.
  6. Valvular heart disease requiring immediate surgical intervention.
  7. History of atrial fibrillation or atrial flutter.
  8. Patent Foramen Ovale (PFO) or PFO where there is or was an indication to start oral anticoagulation
  9. Permanent indication for OAC treatment at enrollment.
  10. Permanent contra-indication for OAC.
  11. Life expectancy less than 1 year.
  12. Pregnancy
  13. An indication for an Implantable Pulse Generator (IPG), Implantable Cardioverter-Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT) or an implantable hemodynamic monitoring system.
  14. Patient otherwise not eligible for the study or adherent for follow-up (e.g. non-resident) or has concurrent disease which may affect clinical outcome (e.g. multiple sclerosis, cancer).

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 ClinicalTrials.gov identifier (NCT number): NCT02937077


Contacts
Layout table for location contacts
Contact: Anne Hege Aamodt, MD, PhD +47 95867270 anhaam@ous-hf.no
Contact: David Russell, MD, PhD +47 23073552 david.russell@uio.no

Locations
Layout table for location information
Norway
Østfold Hospital Trust Recruiting
Sarpsborg, Grålum, Norway, 1714
Contact: Barbara Ratajczak-Tretel, MD    + 47 915 08 600    barbara.ratajczak@so-hf.no   
Oslo University Hospital Recruiting
Oslo, Norway, 0424
Contact: Anne Hege Aamodt, MD PhD    +4723074976    anne.hege.aamodt@ous-hf.no   
Sponsors and Collaborators
Oslo University Hospital
Ostfold Hospital Trust
Haukeland University Hospital
Rigshospitalet, Denmark
Bispebjerg Hospital
St. Olavs Hospital
The Hospital of Vestfold
Sykehuset Telemark
Herlev Hospital
Nordlandssykehuset HF
Vestre Viken Hospital Trust
Helse Stavanger HF
Molde Hospital
Drammen sykehus
Diakonhjemmet Hospital
Investigators
Layout table for investigator information
Principal Investigator: Anne Hege Aamodt, MD, PhD Oslo University Hospital
Study Chair: Dan Atar, MD, PhD Oslo University Hospital

Publications:

Layout table for additonal information
Responsible Party: Anne Hege Aamodt, Dr., Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02937077     History of Changes
Other Study ID Numbers: 2013/2371
First Posted: October 18, 2016    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Plan to share IPD
Keywords provided by Anne Hege Aamodt, Oslo University Hospital:
etiology
Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Atrial Fibrillation
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes