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Atrial FibrillationNOR-FIBNCT02937077

Atrial Fibrillation in Cryptogenic Stroke and TIA

An observational study of Atrial Fibrillation and Ischemic Stroke, run by Oslo University Hospital at 2 sites in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Atrial Fibrillation, Ischemic Stroke, TIA
What is being tested?
Medtronic Reveal LINQ
Type of treatment
Medical device
How many people
259 participants
Where
2 sitesNorway
Study dates
Dec 2016to Oct 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients admitted to stroke units with cryptogenic ischemic stroke or TIA

Who may be able to join

  • Cryptogenic ischemic stroke patients or symptomatic TIA < 21 days from symptom start.
  • 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:
  • Brain MRI or CT†
  • 12-lead ECG for AF detection
  • 24-h ECG monitoring for AF detection and premature atrial complex analysis (e.g. Holter)
  • TEE (transesophageal echocardiography) highly recommended or TTE (transthoracic echocardiography)
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  • Colour Duplex ultrasound examination of the pre-cerebral arteries
  • CTA or MRA of head and neck to rule out other causes of stroke pathologies
  • Age 18 to 80 at onset of TIA/stroke
  • 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.

Who cannot join

  • Known etiology of TIA or stroke.
  • TIA without documented cerebral ischemia on Diffusion Weighed Imaging.
  • Untreated hyperthyroidism
  • Myocardial infarction less than 1 month prior to the stroke or TIA.
  • Coronary bypass grafting less than 1 month prior to the stroke or TIA.
  • Valvular heart disease requiring immediate surgical intervention.
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  • History of atrial fibrillation or atrial flutter.
  • Patent Foramen Ovale (PFO) or PFO where there is or was an indication to start oral anticoagulation
  • Permanent indication for OAC treatment at enrollment.
  • Permanent contra-indication for OAC.
  • Life expectancy less than 1 year.
  • Pregnancy
  • An indication for an Implantable Pulse Generator (IPG), Implantable Cardioverter-Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT) or an implantable hemodynamic monitoring system.
  • 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).

Trial locations and contacts

2 sites in 1 country.

Norway2 sites

  • Oslo University Hospital

    Oslo, 0424

  • Østfold Hospital Trust

    Sarpsborg, Grålum, 1714

Other trials in Norway

About this study

Official title: The Nordic Atrial Fibrillation and Stroke Study

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.

Read more

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.

Being tested
Medtronic Reveal LINQ
Keywords
etiology
Medical subject headings
Atrial Fibrillation, Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Medtronic Reveal LINQDevice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Atrial fibrillation detection rate

    Measured: within 6 months

Secondary outcomes (10)

  1. AF detection rate

    Measured: within 12 months

  2. Levels of miRNAs related to atrial fibrillation

    Measured: 12 months

  3. Levels of NT-proBNP

    Measured: baseline and 12 months

  4. Levels of Troponin-T

    Measured: baseline and 12 months

  5. Levels of inflammation biomarkers

    Measured: baseline and 12 months

  6. Prestroke/pre-TIA CHA2DS2-VASc score

    Measured: 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

    Measured: 12 months

  8. Use of oral anticoagulation - percentage of patients who are using OAC drugs

    Measured: 12 months

  9. Use of antiarrhythmic drugs - percentage of patients who are using antiarrhythmic drugs

    Measured: 12 month

  10. Health Outcome as Evaluated by an EQ-5D Questionnaire - EQ-5D quality of life score

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2016 (estimated)
  2. Study startDec 2016
  3. Primary completionOct 2021
  4. Study completionOct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
259 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02937077
Sponsor's protocol ID
2013/2371
Acronym
NOR-FIB
Status last verified
Jan 2022
First submitted
4 Mar 2016
Last updated
25 Jan 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: Plan to share IPD

Publications

  • Li L, Yiin GS, Geraghty OC, Schulz UG, Kuker W, Mehta Z, Rothwell PM; Oxford Vascular Study. Incidence, outcome, risk factors, and long-term prognosis of cryptogenic transient ischaemic attack and ischaemic stroke: a population-based study. Lancet Neurol. 2015 Sep;14(9):903-913. doi: 10.1016/S1474-4422(15)00132-5. Epub 2015 Jul 27.

    PubMed 26227434

  • Tomson TT, Passman R. The Reveal LINQ insertable cardiac monitor. Expert Rev Med Devices. 2015 Jan;12(1):7-18. doi: 10.1586/17434440.2014.953059. Epub 2014 Aug 26.

    PubMed 25154970

  • Sanna T, Diener HC, Passman RS, Di Lazzaro V, Bernstein RA, Morillo CA, Rymer MM, Thijs V, Rogers T, Beckers F, Lindborg K, Brachmann J; CRYSTAL AF Investigators. Cryptogenic stroke and underlying atrial fibrillation. N Engl J Med. 2014 Jun 26;370(26):2478-86. doi: 10.1056/NEJMoa1313600.

    PubMed 24963567

  • Ziegler PD, Rogers JD, Ferreira SW, Nichols AJ, Sarkar S, Koehler JL, Warman EN, Richards M. Real-World Experience with Insertable Cardiac Monitors to Find Atrial Fibrillation in Cryptogenic Stroke. Cerebrovasc Dis. 2015;40(3-4):175-81. doi: 10.1159/000439063. Epub 2015 Aug 28.

    PubMed 26314298

  • Christensen LM, Krieger DW, Hojberg S, Pedersen OD, Karlsen FM, Jacobsen MD, Worck R, Nielsen H, Aegidius K, Jeppesen LL, Rosenbaum S, Marstrand J, Christensen H. Paroxysmal atrial fibrillation occurs often in cryptogenic ischaemic stroke. Final results from the SURPRISE study. Eur J Neurol. 2014 Jun;21(6):884-9. doi: 10.1111/ene.12400. Epub 2014 Mar 15.

    PubMed 24628954

  • Wu N, Chen X, Cai T, Wu L, Xiang Y, Zhang M, Li Y, Song Z, Zhong L. Association of inflammatory and hemostatic markers with stroke and thromboembolic events in atrial fibrillation: a systematic review and meta-analysis. Can J Cardiol. 2015 Mar;31(3):278-86. doi: 10.1016/j.cjca.2014.12.002. Epub 2014 Dec 9.

    PubMed 25746020

  • Howlett PJ, Hatch FS, Alexeenko V, Jabr RI, Leatham EW, Fry CH. Diagnosing Paroxysmal Atrial Fibrillation: Are Biomarkers the Solution to This Elusive Arrhythmia? Biomed Res Int. 2015;2015:910267. doi: 10.1155/2015/910267. Epub 2015 Jul 1.

    PubMed 26229966

  • Ratajczak-Tretel B, Lambert AT, Al-Ani R, Arntzen K, Bakkejord GK, Bekkeseth HMO, Bjerkeli V, Eldoen G, Gulsvik AK, Halvorsen B, Hoie GA, Ihle-Hansen H, Ingebrigtsen S, Kremer C, Krogseth SB, Kruuse C, Kurz M, Nakstad I, Novotny V, Naess H, Qazi R, Rezaj MK, Rorholt DM, Steffensen LH, Somark J, Tobro H, Truelsen TC, Wassvik L, AEgidius KL, Atar D, Aamodt AH. Underlying causes of cryptogenic stroke and TIA in the nordic atrial fibrillation and stroke (NOR-FIB) study - the importance of comprehensive clinical evaluation. BMC Neurol. 2023 Mar 21;23(1):115. doi: 10.1186/s12883-023-03155-0.

    PubMed 36944929

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation and Ischemic Stroke, run by Oslo University Hospital at 2 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Atrial fibrillation detection rate (time frame: within 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02937077, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2022.

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