NCT01531946

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
199

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

January 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 9, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 13, 2012

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

January 28, 2021

Status Verified

January 1, 2021

Enrollment Period

5.3 years

First QC Date

February 9, 2012

Last Update Submit

January 26, 2021

Conditions

Ischemic Attack, Transient

Keywords

Diffusion Tensor Imaging

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

MRI ScanPROCEDURE

Patients 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.

Eligibility Criteria

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

Patients admitted to the stroke ward at Bispebjerg University Hospital with signs of TIA.

You may qualify if:

  • Clinical signs of TIA
  • Informed consent
  • No serious respiratory or cardiac implications

You may not qualify if:

  • Contraindications to MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg Hospital

Copenhagen, Capital Region, DK-2400, Denmark

Location

Related Publications (6)

  • 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.

    PMID: 19200786BACKGROUND

  • 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.

    PMID: 21157338BACKGROUND

  • 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. doi: 10.1016/j.mric.2006.06.005.

    PMID: 16873008BACKGROUND

  • Havsteen 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.

    PMID: 30126352DERIVED

  • Havsteen 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.

    PMID: 29358426DERIVED

  • Havsteen 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.

    PMID: 29326651DERIVED

MeSH Terms

Conditions

Ischemic Attack, Transient

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Brain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Hanne Christensen, MD, DMSci

    Department of Neurology and Cerebrovascular Diseases, Bispebjerg Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Research Professor, Consultant Neurologist

Study Record Dates

First Submitted

February 9, 2012

First Posted

February 13, 2012

Study Start

January 1, 2012

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

January 28, 2021

Record last verified: 2021-01

Locations

DK(1)