Atrial Fibrillation in Cryptogenic Stroke and TIA

NCT ID: NCT02937077

Last Updated: 2022-01-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 259 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2021-10-31

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.

Conditions

Atrial Fibrillation; Ischemic Stroke; TIA

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Medtronic Reveal LINQ

Intervention Type: DEVICE

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ostfold Hospital Trust

OTHER

Sponsor Role: collaborator

Haukeland University Hospital

OTHER

Sponsor Role: collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role: collaborator

Bispebjerg Hospital

OTHER

Sponsor Role: collaborator

The Hospital of Vestfold

OTHER

Sponsor Role: collaborator

Sykehuset Telemark

OTHER_GOV

Sponsor Role: collaborator

Herlev Hospital

OTHER

Sponsor Role: collaborator

Nordlandssykehuset HF

OTHER

Sponsor Role: collaborator

Vestre Viken Hospital Trust

OTHER

Sponsor Role: collaborator

Helse Stavanger HF

OTHER_GOV

Sponsor Role: collaborator

Molde Hospital

OTHER

Sponsor Role: collaborator

Drammen sykehus

OTHER

Sponsor Role: collaborator

Diakonhjemmet Hospital

OTHER

Sponsor Role: collaborator

University Hospital of North Norway

OTHER

Sponsor Role: collaborator

Ullevaal University Hospital

OTHER

Sponsor Role: collaborator

Sykehuset Innlandet HF

OTHER

Sponsor Role: collaborator

Skane University Hospital

OTHER

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Anne Hege Aamodt

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anne Hege Aamodt, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Dan Atar, MD, PhD

Role: STUDY_CHAIR

Oslo University Hospital

Locations

Østfold Hospital Trust

Sarpsborg, Grålum, Norway

Oslo University Hospital

Oslo, , Norway

Countries

Norway

References

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Reference Type: BACKGROUND

PMID: 26227434 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25154970 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24963567 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26314298 (View on PubMed)

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.

Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

PMID: 25746020 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26229966 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36944929 (View on PubMed)

Other Identifiers

2013/2371

Identifier Type: -

Identifier Source: org_study_id