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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01531946
Other study ID # H-1-2011-75
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2012
Est. completion date May 2017

Study information

Verified date January 2021
Source Bispebjerg Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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. 1,5 tesla gradient echo and 3 tesla Susceptibility weighted imaging (SWI) to detect microbleed as sign of small vessel disease. 2. Axial T2 FLAIR to detect white matter lesions. 3. 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: 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. (Total additional scantime 10min) All in All 20min in the scanner.


Recruitment information / eligibility

Status Completed
Enrollment 199
Est. completion date May 2017
Est. primary completion date May 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Clinical signs of TIA - Informed consent - No serious respiratory or cardiac implications Exclusion Criteria: - Contraindications to MRI

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
MRI Scan
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.

Locations

Country Name City State
Denmark Bispebjerg Hospital Copenhagen Capital Region

Sponsors (1)

Lead Sponsor Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (3)

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. — View Citation

Olivot 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. Review. — View Citation

Schaefer 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 on first MRI
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