NCT02606890

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2015

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

Study Start

First participant enrolled

August 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 17, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 8, 2016

Status Verified

December 1, 2016

Enrollment Period

1.2 years

First QC Date

November 13, 2015

Last Update Submit

December 7, 2016

Conditions

Keywords

Magnetic Resonance ImagingStroke Lesion PatternAtrial FibrillationStroke

Outcome Measures

Primary Outcomes (1)

  • Lesion pattern on Magnetic Resonance Imaging in acute stroke patients

    Stroke lesion pattern on MRI is assessed.

    within 7 days after stroke onset

Secondary Outcomes (1)

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

    within 7 days after stroke onset

Interventions

MRIOTHER

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.

Eligibility Criteria

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

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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.

    PMID: 26182860BACKGROUND
  • 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.

    PMID: 23765944BACKGROUND
  • 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.

    PMID: 24646875BACKGROUND
  • 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.

    PMID: 14676047BACKGROUND
  • 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.

    PMID: 21865573BACKGROUND
  • 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;2004(2):CD000185. doi: 10.1002/14651858.CD000185.pub2.

    PMID: 15106146BACKGROUND
  • 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.

    PMID: 22377874BACKGROUND

MeSH Terms

Conditions

StrokeAtrial Fibrillation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesArrhythmias, CardiacHeart DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Christian H Nolte, PD Dr. med.

    Center for stroke Research Berlin, Charite-Universitätsmedizin, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant, OA PD Dr. med.

Study Record Dates

First Submitted

November 13, 2015

First Posted

November 17, 2015

Study Start

August 1, 2015

Primary Completion

October 1, 2016

Study Completion

December 1, 2016

Last Updated

December 8, 2016

Record last verified: 2016-12