Ischemic Attack, TransientNCT01531946
Acute MRI in Transient Ischemic Attack
An observational study of Ischemic Attack, Transient, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to detect acute ischemic lesions in patients admitted with symptoms of transient ischemic attack (TIA). Diffusion weighted Imaging (DWI) is today one of the best ways to detect ischemic lesions after TIA. The problem is that this only gives the diagnosis in 30% of the cases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Attack, Transient
- What is being tested?
- MRI Scan
- Type of treatment
- Surgery or procedure
- How many people
- 199 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2012to May 2017
- 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 admitted to the stroke ward at Bispebjerg University Hospital with signs of TIA.
Who may be able to join
- Clinical signs of TIA
- Informed consent
- No serious respiratory or cardiac implications
Who cannot join
- Contraindications to MRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute MRI-techniques for the Detection of Ischemic Lesions After Transient Ischemic Attack
The purpose of this study is to detect acute ischemic lesions in patients admitted with symptoms of transient ischemic attack (TIA).
Diffusion weighted Imaging (DWI) is today one of the best ways to detect ischemic lesions after TIA. The problem is that this only gives the diagnosis in 30% of the cases.
It is possible that the addition of Arterial spin labeling (ASL) perfusion imaging and diffusion tensor imaging will make it possible to give a more accurate diagnosis.
Read the detailed description
The purpose of this study is to detect acute ischemic lesions in patients admitted with symptoms of transient ischemic attack (TIA).
Diffusion weighted Imaging (DWI) is today one of the best ways to detect ischemic lesions after TIA. The problem is that this only gives the diagnosis in 30% of the cases.
It is possible that the addition of ASL-perfusion imaging and diffusion tensor imaging will make it possible to give a more accurate and selective diagnosis of TIA.
Patients admitted with clinical signs of TIA can be included. Patients will be examined with the TIA protocol in reference to the standardized clinical care:
- 1,5 tesla gradient echo and 3 tesla Susceptibility weighted imaging (SWI) to detect microbleed as sign of small vessel disease.
- Axial T2 FLAIR to detect white matter lesions.
- Axial DWI to detect areas with impeded diffusion. (Total scantime 10min)
If no signs of ischemic lesions is detected the following additional research scan-protocol will be initiated:
- Perfusion without contrast: Arterial spin labeling (ASL) with the ability of showing signs of ischemia.
- Diffusion tensor imaging (DTI): Has a higher sensitivity than DWI in displaying local ischemic lesions. (Total additional scantime 10min)
All in All 20min in the scanner.
- Conditions
- Ischemic Attack, Transient
- Being tested
- MRI Scan
- Keywords
- Diffusion Tensor Imaging
- Medical subject headings
- Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI ScanProcedure or surgery
Patients will have to spend additional 10min in the scanner.
Additional scan modalities used:
- Perfusion without contrast: Arterial spin labeling (ASL) with the ability of showing signs of ischemia.
- Diffusion tensor imaging (DTI): Has a higher sensitivity than DWI in displaying local ischemic lesions.
An overall 20min scan period.
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of patients with ischaemic lessions on DTI
We want to assess the frequency of patients in whom a diffusion restricted lesion can only be observed on DTI
Measured: on first MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Ischemic Attack, TransientStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanne Christensen, Bispebjerg Hospital
- Investigators
- Hanne Christensen, MD, DMSci, Principal investigator, Department of Neurology and Cerebrovascular Diseases, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01531946
- Sponsor's protocol ID
- H-1-2011-75
- Status last verified
- Jan 2021
- First submitted
- 9 Feb 2012
- Last updated
- 28 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Luengo-Fernandez R, Gray AM, Rothwell PM. Effect of urgent treatment for transient ischaemic attack and minor stroke on disability and hospital costs (EXPRESS study): a prospective population-based sequential comparison. Lancet Neurol. 2009 Mar;8(3):235-43. doi: 10.1016/S1474-4422(09)70019-5. Epub 2009 Feb 4.
PubMed 19200786Olivot JM, Albers GW. Diffusion-perfusion MRI for triaging transient ischemic attack and acute cerebrovascular syndromes. Curr Opin Neurol. 2011 Feb;24(1):44-9. doi: 10.1097/WCO.0b013e328341f8a5.
PubMed 21157338Schaefer PW, Copen WA, Lev MH, Gonzalez RG. Diffusion-weighted imaging in acute stroke. Magn Reson Imaging Clin N Am. 2006 May;14(2):141-68. doi: 10.1016/j.mric.2006.06.005.
PubMed 16873008Havsteen I, Willer L, Ovesen C, Nybing JD, AEgidius K, Marstrand J, Meden P, Rosenbaum S, Folke MN, Christensen H, Christensen A. Significance of arterial spin labeling perfusion and susceptibility weighted imaging changes in patients with transient ischemic attack: a prospective cohort study. BMC Med Imaging. 2018 Aug 20;18(1):24. doi: 10.1186/s12880-018-0264-6.
PubMed 30126352Havsteen I, Ovesen C, Willer L, Nybing JD, AEgidius K, Marstrand J, Meden P, Rosenbaum S, Folke MN, Christensen H, Christensen A. Small cortical grey matter lesions show no persistent infarction in transient ischaemic attack? A prospective cohort study. BMJ Open. 2018 Jan 21;8(1):e018160. doi: 10.1136/bmjopen-2017-018160.
PubMed 29358426Havsteen I, Ovesen C, Willer L, Nybing JD, AEgidius K, Marstrand J, Meden P, Rosenbaum S, Folke MN, Christensen H, Christensen A. Comparison of 3- and 20-Gradient Direction Diffusion-Weighted Imaging in a Clinical Subacute Cohort of Patients with Transient Ischemic Attack: Application of Standard Vendor Protocols for Lesion Detection and Final Infarct Size Projection. Front Neurol. 2017 Dec 18;8:691. doi: 10.3389/fneur.2017.00691. eCollection 2017.
PubMed 29326651
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute MRI-techniques for the Detection of Ischemic Lesions After Transient Ischemic Attack
- ClinicalTrials.gov ID
- NCT01531946
- Acronym / sponsor ID
- H-1-2011-75
- Conditions
- Ischemic Attack, Transient
- Keywords
- Diffusion Tensor Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 13 Feb 2012 (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 purpose of this study is to detect acute ischemic lesions in patients admitted with symptoms of transient ischemic attack (TIA).
Diffusion weighted Imaging (DWI) is today one of the best ways to detect ischemic lesions after TIA. The problem is that this only gives the diagnosis in 30% of the cases.
It is possible that the addition of Arterial spin labeling (ASL) perfusion imaging and diffusion tensor imaging will make it possible to give a more accurate diagnosis.
Detailed description
The purpose of this study is to detect acute ischemic lesions in patients admitted with symptoms of transient ischemic attack (TIA).
Diffusion weighted Imaging (DWI) is today one of the best ways to detect ischemic lesions after TIA. The problem is that this only gives the diagnosis in 30% of the cases.
It is possible that the addition of ASL-perfusion imaging and diffusion tensor imaging will make it possible to give a more accurate and selective diagnosis of TIA.
Patients admitted with clinical signs of TIA can be included. Patients will be examined with the TIA protocol in reference to the standardized clinical care:
- 1,5 tesla gradient echo and 3 tesla Susceptibility weighted imaging (SWI) to detect microbleed as sign of small vessel disease.
- Axial T2 FLAIR to detect white matter lesions.
- Axial DWI to detect areas with impeded diffusion. (Total scantime 10min)
If no signs of ischemic lesions is detected the following additional research scan-protocol will be initiated:
- Perfusion without contrast: Arterial spin labeling (ASL) with the ability of showing signs of ischemia.
- Diffusion tensor imaging (DTI): Has a higher sensitivity than DWI in displaying local ischemic lesions. (Total additional scantime 10min)
All in All 20min in the scanner.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the stroke ward at Bispebjerg University Hospital with signs of TIA.
Key inclusion criteria (3 listed)
- Clinical signs of TIA
- Informed consent
- No serious respiratory or cardiac implications
Key exclusion criteria (1 listed)
- Contraindications to MRI
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 |
|---|---|---|
| MRI ScanPatients will have to spend additional 10min in the scanner. Additional scan modalities used: 1. Perfusion without contrast: Arterial spin labeling (ASL) with the ability of showing signs of ischemia. 2. Diffusion tensor imaging (DTI): Has a higher sensitivity than DWI in displaying local ischemic lesions. An overall 20min scan period. | Procedure or surgery | – |
Primary outcome
frequency of patients with ischaemic lessions on DTI
Time frame: on first MRI
We want to assess the frequency of patients in whom a diffusion restricted lesion can only be observed on DTI
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 28 Jan 2021.
- Background: PubMed 19200786Luengo-Fernandez R, Gray AM, Rothwell PM. Effect of urgent treatment for transient ischaemic attack and minor stroke on disability and hospital costs (EXPRESS study): a prospective population-based sequential comparison. Lancet Neurol. 2009 Mar;8(3):235-43. doi: 10.1016/S1474-4422(09)70019-5. Epub 2009 Feb 4.
- Background: PubMed 21157338Olivot JM, Albers GW. Diffusion-perfusion MRI for triaging transient ischemic attack and acute cerebrovascular syndromes. Curr Opin Neurol. 2011 Feb;24(1):44-9. doi: 10.1097/WCO.0b013e328341f8a5.
- Background: PubMed 16873008Schaefer PW, Copen WA, Lev MH, Gonzalez RG. Diffusion-weighted imaging in acute stroke. Magn Reson Imaging Clin N Am. 2006 May;14(2):141-68. doi: 10.1016/j.mric.2006.06.005.
- Derived from this study: PubMed 30126352Havsteen I, Willer L, Ovesen C, Nybing JD, AEgidius K, Marstrand J, Meden P, Rosenbaum S, Folke MN, Christensen H, Christensen A. Significance of arterial spin labeling perfusion and susceptibility weighted imaging changes in patients with transient ischemic attack: a prospective cohort study. BMC Med Imaging. 2018 Aug 20;18(1):24. doi: 10.1186/s12880-018-0264-6.
- Derived from this study: PubMed 29358426Havsteen I, Ovesen C, Willer L, Nybing JD, AEgidius K, Marstrand J, Meden P, Rosenbaum S, Folke MN, Christensen H, Christensen A. Small cortical grey matter lesions show no persistent infarction in transient ischaemic attack? A prospective cohort study. BMJ Open. 2018 Jan 21;8(1):e018160. doi: 10.1136/bmjopen-2017-018160.
- Derived from this study: PubMed 29326651Havsteen I, Ovesen C, Willer L, Nybing JD, AEgidius K, Marstrand J, Meden P, Rosenbaum S, Folke MN, Christensen H, Christensen A. Comparison of 3- and 20-Gradient Direction Diffusion-Weighted Imaging in a Clinical Subacute Cohort of Patients with Transient Ischemic Attack: Application of Standard Vendor Protocols for Lesion Detection and Final Infarct Size Projection. Front Neurol. 2017 Dec 18;8:691. doi: 10.3389/fneur.2017.00691. eCollection 2017.
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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.
Hanne Christensen, MD, DMSci principal investigator
Department of Neurology and Cerebrovascular Diseases, Bispebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Attack, Transient, run by Bispebjerg Hospital at 1 site in Denmark.
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 1 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 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
frequency of patients with ischaemic lessions on DTI (time frame: on first MRI). 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 NCT01531946, which also lists 6 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 28 Jan 2021.