NCT02937077

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
259

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2016

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2016

Completed
8 months until next milestone

First Posted

Study publicly available on registry

October 18, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

January 25, 2022

Status Verified

January 1, 2022

Enrollment Period

4.8 years

First QC Date

March 4, 2016

Last Update Submit

January 9, 2022

Conditions

Atrial FibrillationIschemic StrokeTIA

Keywords

etiology

Outcome Measures

Primary Outcomes (1)

  • Atrial fibrillation detection rate

    within 6 months

Secondary Outcomes (10)

  • AF detection rate

    within 12 months

  • Levels of miRNAs related to atrial fibrillation

    12 months

  • Levels of NT-proBNP

    baseline and 12 months

  • Levels of Troponin-T

    baseline and 12 months

  • Levels of inflammation biomarkers

    baseline and 12 months

  • +5 more secondary outcomes

Interventions

Medtronic Reveal LINQDEVICE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to stroke units with cryptogenic ischemic stroke or TIA

You may qualify if:

  • Cryptogenic ischemic stroke patients or symptomatic TIA \< 21 days from symptom start.
  • Brain MRI or CT†
  • lead ECG for AF detection
  • h ECG monitoring for AF detection and premature atrial complex analysis (e.g. Holter)
  • TEE (transesophageal echocardiography) highly recommended or TTE (transthoracic echocardiography)
  • 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.

You may not qualify if:

  • 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.
  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Østfold Hospital Trust

Sarpsborg, Grålum, 1714, Norway

Location

Oslo University Hospital

Oslo, 0424, Norway

Location

Related Publications (8)

  • 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.

    PMID: 26227434BACKGROUND

  • 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.

    PMID: 25154970BACKGROUND

  • 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.

    PMID: 24963567BACKGROUND

  • 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.

    PMID: 26314298BACKGROUND

  • 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.

    PMID: 24628954BACKGROUND

  • 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.

    PMID: 25746020BACKGROUND

  • 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.

    PMID: 26229966BACKGROUND

  • 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.

    PMID: 36944929DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood samples

MeSH Terms

Conditions

Atrial FibrillationIschemic Stroke

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsStrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular Diseases

Study Officials

  • Anne Hege Aamodt, MD, PhD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

  • Dan Atar, MD, PhD

    Oslo University Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

March 4, 2016

First Posted

October 18, 2016

Study Start

December 1, 2016

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

January 25, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will share

Plan to share IPD

Locations

NO(2)