StrokeSLPAFNCT02606890
Stroke Lesion Pattern on MRI and Atrial Fibrillation
An observational study of Stroke and Atrial Fibrillation, run by Charite University, Berlin, Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Atrial Fibrillation
- What is being tested?
- MRI
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Dec 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute ischemic stroke proven by MRI admitted to Department of Neurology, Charite Campus Benjamin Franklin
Who may be able to join
- 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
Who cannot join
- unable to undergo MRI
- lack of data on heart rhythm
About this study
Official title: Is the Lesion Pattern on Magnetic Resonance Imaging in Acute Ischemic Stroke Patients Associated With Atrial Fibrillation?
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.
Read more
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.
- Conditions
- Stroke, Atrial Fibrillation
- Being tested
- MRI
- Keywords
- Magnetic Resonance Imaging, Stroke Lesion Pattern, Atrial Fibrillation, Stroke
- Medical subject headings
- Stroke, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesion pattern on Magnetic Resonance Imaging in acute stroke patients
Stroke lesion pattern on MRI is assessed.
Measured: 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)
Measured: within 7 days after stroke onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2015 (estimated)
- Study startAug 2015
- Primary completionOct 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Nolte, Charite University, Berlin, Germany
- Investigators
- Christian H Nolte, PD Dr. med., Principal investigator, Center for stroke Research Berlin, Charite-Universitätsmedizin, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02606890
- Sponsor's protocol ID
- AGNO_001
- Acronym
- SLPAF
- Status last verified
- Dec 2016
- First submitted
- 13 Nov 2015
- Last updated
- 8 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
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 26182860Braemswig 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 23765944Hart 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 24646875Kang 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 14676047Koennecke 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 21865573Saxena 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.
PubMed 15106146Tatu 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Lesion Pattern on Magnetic Resonance Imaging in Acute Ischemic Stroke Patients Associated With Atrial Fibrillation?
- ClinicalTrials.gov ID
- NCT02606890
- Acronym / sponsor ID
- SLPAF / AGNO_001
- Conditions
- Stroke, Atrial Fibrillation
- Keywords
- Magnetic Resonance Imaging, Stroke Lesion Pattern, Atrial Fibrillation, Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 17 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute ischemic stroke proven by MRI admitted to Department of Neurology, Charite Campus Benjamin Franklin
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- unable to undergo MRI
- lack of data on heart rhythm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIStroke 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. | Other | – |
Primary outcome
Lesion pattern on Magnetic Resonance Imaging in acute stroke patients
Time frame: within 7 days after stroke onset
Stroke lesion pattern on MRI is assessed.
1 secondary outcome
Lesion pattern on Magnetic Resonance Imaging in acute stroke patients (DWI only)
Time frame: within 7 days after stroke onset
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2016.
- Background: PubMed 26182860Bernstein 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.
- Background: PubMed 23765944Braemswig 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.
- Background: PubMed 24646875Hart 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.
- Background: PubMed 14676047Kang 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.
- Background: PubMed 21865573Koennecke 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.
- Background: PubMed 15106146Saxena 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.
- Background: PubMed 22377874Tatu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian H Nolte, PD Dr. med. principal investigator
Center for stroke Research Berlin, Charite-Universitätsmedizin, Berlin, Germany
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Atrial Fibrillation, run by Charite University, Berlin, Germany.
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 3 inclusion and 2 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 8 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Lesion pattern on Magnetic Resonance Imaging in acute stroke patients (time frame: within 7 days after stroke onset). 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 NCT02606890, which also lists 7 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 8 Dec 2016.