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CompletedNCT02606890SLPAFUpdated Dec 8, 2016

Stroke Lesion Pattern on MRI and Atrial Fibrillation

An observational study in Stroke and Atrial Fibrillation, sponsored by Charite University, Berlin, Germany. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-12-08.

Sponsored by Charite University, Berlin, Germany · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
01

Study summary

The aim of this retrospective cohort study is to investigate the relationship between lesion pattern on Magnetic Resonance Imaging (MRI) and atrial fibrillation in patients with acute ischemic stroke. The investigators hypothesize that a pattern with lesions located in at least two of the main arterial territories of the brain (left or right internal carotid artery or posterior circulation territory) is associated with atrial fibrillation.

The investigators will retrospectively analyze clinical data and imaging lesion pattern of 1000 consecutive patients who were admitted to the Department of Neurology (Charite - Universitätsmedizin Berlin, Campus Benjamin Franklin) and diagnosed with acute ischemic stroke.

Acute stroke patients of this cohort underwent 3-Tesla MRI with Diffusion-weighted Imaging (DWI) and Fluid-attenuated Inversion Recovery (FLAIR) sequences as well as standard 12-lead electrocardiography (ECG) on admission and cardiac monitoring with automated arrhythmia detection during stroke unit care lasting at least 24 hours.

If DWI and FLAIR lesions are located in more than one of the main arterial territories, lesion pattern will be categorized as "multiple lesion pattern".

The investigators hypothesize that a multiple lesion pattern will be detected more frequently in acute stroke patients with atrial fibrillation than in patients without atrial fibrillation.

The findings of this study might help to identify patients who could profit from extended diagnostic work-up in order to detect atrial fibrillation.

Read the detailed description

Introduction

Atrial fibrillation is the most common cause of cardioembolic stroke and can be detected in about 27% of acute stroke patients treated on stroke units in Berlin. Stroke patients in whom atrial fibrillation is detected benefit from anticoagulation rather than anti-aggregation as a secondary prevention treatment. Lesions on brain imaging that are located in more than one of the main arterial territories of the brain may indicate cardioembolic etiology. Cardioembolic etiology is mainly due to atrial fibrillation. Atrial fibrillation causes cardiac emboli that may embolize in all brain arteries while other embolic sources e.g. carotid plaque cannot. However, current data on the association between lesion patterns and atrial fibrillation are inconclusive.

Purpose

The aim of this retrospective cohort study is to investigate the relationship between lesion pattern on Magnetic Resonance Imaging (MRI) and atrial fibrillation. The investigators hypothesize that a lesion pattern with brain lesions in more than one of the main arterial territories of the brain (left or right internal carotid artery or posterior circulation territory) is associated with atrial fibrillation in patients with acute ischemic stroke. The findings of this study might help to identify patients with atrial fibrillation.

Methods

Blinded for clinical data the investigators will analyze imaging data and radiologic reports of 1000 consecutive stroke patients who received 3-Tesla MRI imaging including Diffusion-weighted Imaging (DWI) and Fluid-attenuated Inversion Recovery (FLAIR) sequence. DWI lesions correspond to acute stroke and FLAIR lesions to subacute and chronic stroke. Brain lesions will be attributed to a vascular territory (left or right internal carotid artery or posterior circulation territory) and the pattern consecutively categorized as "single", "scattered" and "multiple" as described by Braemswig et al..

Fetal origin of the posterior cerebral artery and variability of vascular territories will be taken into account. Vascular territory attribution in ambiguous cases will be conducted by consensus between investigators. Demographic and clinical data will be collected from medical records. Strokes meeting the criteria for Embolic Stroke of Unknown Source (ESUS) will be identified according to Hart et al..

Based on a pilot study including 250 patients the investigators estimate that atrial fibrillation will be present in 38% of patients with a multiple lesion pattern on MRI and in 28% of patients with a non-multiple pattern. Based on these assumptions, 894 patients are required to have a 80% chance of detecting, (as significant at the 5% level), a difference of 10% with 28% atrial fibrillation in patients without multiple lesion pattern and 38% atrial fibrillation in patients with a multiple lesion pattern.

In accordance with legislation in Berlin, Germany, an ethics committee approval is not required for this study.

Outcomes

Primary outcome is multiple lesion pattern on MRI (DWI and FLAIR). Secondary Outcome is multiple lesion pattern on MRI (DWI lesions only) Analyses will be conducted comparing

  • Patients with and without atrial fibrillation
  • Patients with newly diagnosed atrial fibrillation and patients without atrial fibrillation
  • Patients with newly diagnosed atrial fibrillation and patients with known atrial fibrillation
  • Patients fulfilling ESUS criteria and patients who do not
  • Patients with brain lesions outside of the overlap area of the main vascular territories as defined by Tatu et al.
02

Conditions studied

  • Stroke
  • Atrial Fibrillation

Keywords

  • Magnetic Resonance Imaging
  • Stroke Lesion Pattern
  • Atrial Fibrillation
  • Stroke
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 1,000 is above the median of 160 across 1,692 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Charite University, Berlin, Germany is the lead sponsor of 836 studies on the registry; 129 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with acute ischemic stroke proven by MRI admitted to Department of Neurology, Charite Campus Benjamin Franklin

Inclusion criteria

  • Acute ischemic stroke, defined as the presence of at least one DWI lesion and clinical signs of stroke
  • underwent cerebral MRI imaging: DWI (diffusion-weighed imaging), FLAIR (Fluid-attenuated Inversion Recovery)
  • admission to stroke unit at the Department of Neurology, Charite Campus Benjamin Franklin

Exclusion criteria

Exclusion Criteria:

  • unable to undergo MRI
  • lack of data on heart rhythm
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,000 participants (actual)
Patient registry
No

Interventions

  • OtherMRI

    Stroke patients routinely undergo MRI at Charite Campus Benjamin Franklin. Type of MRI stroke pattern is evaluated with regard to presence or detection of (new) atrial fibrillation.

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What researchers measure

Primary outcomes

  1. Lesion pattern on Magnetic Resonance Imaging in acute stroke patients

    Stroke lesion pattern on MRI is assessed.

    Time frame: within 7 days after stroke onset

Secondary outcomes

  1. Lesion pattern on Magnetic Resonance Imaging in acute stroke patients (DWI only)

    Stroke lesion pattern on MRI is assessed (DWI only)

    Time frame: within 7 days after stroke onset

07

Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Bernstein RA, Di Lazzaro V, Rymer MM, Passman RS, Brachmann J, Morillo CA, Sanna T, Thijs V, Rogers T, Liu S, Ziegler PD, Diener HC. Infarct Topography and Detection of Atrial Fibrillation in Cryptogenic Stroke: Results from CRYSTAL AF. Cerebrovasc Dis. 2015;40(1-2):91-6. doi: 10.1159/000437018. Epub 2015 Jul 11. PubMed 26182860 ↗
  • Braemswig TB, Usnich T, Albach FN, Brunecker P, Grittner U, Scheitz JF, Fiebach JB, Nolte CH. Early new diffusion-weighted imaging lesions appear more often in stroke patients with a multiple territory lesion pattern. Stroke. 2013 Aug;44(8):2200-4. doi: 10.1161/STROKEAHA.111.000810. Epub 2013 Jun 13. PubMed 23765944 ↗
  • Hart RG, Diener HC, Coutts SB, Easton JD, Granger CB, O'Donnell MJ, Sacco RL, Connolly SJ; Cryptogenic Stroke/ESUS International Working Group. Embolic strokes of undetermined source: the case for a new clinical construct. Lancet Neurol. 2014 Apr;13(4):429-38. doi: 10.1016/S1474-4422(13)70310-7. PubMed 24646875 ↗
  • Kang DW, Chalela JA, Ezzeddine MA, Warach S. Association of ischemic lesion patterns on early diffusion-weighted imaging with TOAST stroke subtypes. Arch Neurol. 2003 Dec;60(12):1730-4. doi: 10.1001/archneur.60.12.1730. PubMed 14676047 ↗
  • Koennecke HC, Belz W, Berfelde D, Endres M, Fitzek S, Hamilton F, Kreitsch P, Mackert BM, Nabavi DG, Nolte CH, Pohls W, Schmehl I, Schmitz B, von Brevern M, Walter G, Heuschmann PU; Berlin Stroke Register Investigators. Factors influencing in-hospital mortality and morbidity in patients treated on a stroke unit. Neurology. 2011 Sep 6;77(10):965-72. doi: 10.1212/WNL.0b013e31822dc795. Epub 2011 Aug 24. PubMed 21865573 ↗
  • Saxena R, Koudstaal PJ. Anticoagulants for preventing stroke in patients with nonrheumatic atrial fibrillation and a history of stroke or transient ischaemic attack. Cochrane Database Syst Rev. 2004;(2):CD000185. doi: 10.1002/14651858.CD000185.pub2. PubMed 15106146 ↗
  • Tatu L, Moulin T, Vuillier F, Bogousslavsky J. Arterial territories of the human brain. Front Neurol Neurosci. 2012;30:99-110. doi: 10.1159/000333602. Epub 2012 Feb 14. PubMed 22377874 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02606890
Lead sponsor
Charite University, Berlin, Germany
Responsible party
Christian Nolte (Consultant, OA PD Dr. med., Charite University, Berlin, Germany) — Principal investigator
First posted
Nov 17, 2015
Start date
Aug 2015
Primary completion
Oct 2016
Completion
Dec 2016
Last update
Dec 8, 2016

Study contacts

Christian H Nolte, PD Dr. med.
principal investigator · Center for stroke Research Berlin, Charite-Universitätsmedizin, Berlin, Germany

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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