Diagnosis of TIATIANCT04108754
Small-vessel Disease Burden and Early Risk of Stroke After Transient Ischemic Attack
An observational study of Diagnosis of TIA and MRI, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Predicting the risk of stroke remains a challenge in the management of transient ischemic attack (TIA). In addition to clinical variables, morphological features such as the presence of a diffusion weighted sequence (DWI) lesion and carotid stenosis of at least 50% improve risk stratification and are considered in the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diagnosis of TIA, MRI
- What is being tested?
- microangiopathic burden
- How many people
- 376 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2018to 1 Dec 2018
- 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: All patients in the neurovascular unit of the Neurological Hospital of Lyon between 01/01/2016 and 30/12/2017 with a probable diagnosis of TIA and having an MRI within 7 days of the TIA.
Who may be able to join
- Patients with probable TIA with Regression of symptoms within 24 hours (unilateral motor or sensory disorders affecting the face and / or limbs , language disorder, blindness of an eye or amputation of a visual field)
- Patients with possible AIT with 2 of these symptoms associated: fear of heights, diplopia, dysarthria, disorders of swallowing, loss of balance, isolated sensory symptoms affecting only part of a limb or hemiface.
- Patient who have had a brain MRI.
- Patient over 18 year-old.
- Patient who give their non opposition to participate at the study.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Predicting the risk of stroke remains a challenge in the management of transient ischemic attack (TIA). In addition to clinical variables, morphological features such as the presence of a diffusion weighted sequence (DWI) lesion and carotid stenosis of at least 50% improve risk stratification and are considered in the literature. score ABCD3-I1. Several studies have shown that brain microhemorrhages are associated with the risk of early stroke in patients with TIA. Data on white matter hypersignals on the T2-weighted sequence or FLAIR (FLuid Attenuated Inversion Recovery) are more conflicting. The global microangiopathic load, including the gaps, the hypersignals of the white matter, the perivascular spaces visible on MRI in the basal ganglia, especially when they are very numerous (> 20) and the gaps, have recently been described as being associated with stroke risk within 2 to 3 years of TIA or ischemic stroke. To date, the predictive value of global microangiopathic burden on early stroke risk in the course of TIA is not known.
- Conditions
- Diagnosis of TIA, MRI
- Being tested
- microangiopathic burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microangiopathic burdenOther
to determine the value of the global microangiopathic burden on the prediction of early stroke risk in a homogeneous cohort of TIA.
| Study group | Role | What they receive |
|---|---|---|
| Diagnosis of AIT | Patients in the neurovascular unit of the Neurological Hospital of Lyon between 01/01/2016 and 30/12/2017 with a probable diagnosis of AIT and having an MRI within 7 days of TIA. Receives: Other: microangiopathic burden |
What is being measured
The primary outcome is the main question the study is designed to answer.
stroke recurrence within 90 days,
The stroke recurrence within 90 days is determined via a clinical consultation or telephone call to the patient with a structured questionnaire.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start1 Aug 2018
- Primary completion1 Aug 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnosis of TIAStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- 376 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Norbert NIGHOGHOSSIAN, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04108754
- Sponsor's protocol ID
- TIA
- Acronym
- TIA
- Status last verified
- Sep 2019
- First submitted
- 26 Sep 2019
- Last updated
- 30 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Small-vessel Disease Burden and Early Risk of Stroke After Transient Ischemic Attack
- ClinicalTrials.gov ID
- NCT04108754
- Acronym / sponsor ID
- TIA / TIA
- Conditions
- Diagnosis of TIA, MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 376 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 30 Sep 2019 (actual)
- 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.
Predicting the risk of stroke remains a challenge in the management of transient ischemic attack (TIA). In addition to clinical variables, morphological features such as the presence of a diffusion weighted sequence (DWI) lesion and carotid stenosis of at least 50% improve risk stratification and are considered in the literature. score ABCD3-I1. Several studies have shown that brain microhemorrhages are associated with the risk of early stroke in patients with TIA. Data on white matter hypersignals on the T2-weighted sequence or FLAIR (FLuid Attenuated Inversion Recovery) are more conflicting. The global microangiopathic load, including the gaps, the hypersignals of the white matter, the perivascular spaces visible on MRI in the basal ganglia, especially when they are very numerous (> 20) and the gaps, have recently been described as being associated with stroke risk within 2 to 3 years of TIA or ischemic stroke. To date, the predictive value of global microangiopathic burden on early stroke risk in the course of TIA is not known.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnosis of AIT | – | Other: microangiopathic burdenPatients in the neurovascular unit of the Neurological Hospital of Lyon between 01/01/2016 and 30/12/2017 with a probable diagnosis of AIT and having an MRI within 7 days of TIA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients in the neurovascular unit of the Neurological Hospital of Lyon between 01/01/2016 and 30/12/2017 with a probable diagnosis of TIA and having an MRI within 7 days of the TIA.
Key inclusion criteria (5 listed)
- Patients with probable TIA with Regression of symptoms within 24 hours (unilateral motor or sensory disorders affecting the face and / or limbs , language disorder, blindness of an eye or amputation of a visual field)
- Patients with possible AIT with 2 of these symptoms associated: fear of heights, diplopia, dysarthria, disorders of swallowing, loss of balance, isolated sensory symptoms affecting only part of a limb or hemiface.
- Patient who have had a brain MRI.
- Patient over 18 year-old.
- Patient who give their non opposition to participate at the study.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| microangiopathic burdento determine the value of the global microangiopathic burden on the prediction of early stroke risk in a homogeneous cohort of TIA. | Other | Diagnosis of AIT |
Primary outcome
stroke recurrence within 90 days,
Time frame: 90 days
The stroke recurrence within 90 days is determined via a clinical consultation or telephone call to the patient with a structured questionnaire.
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 30 Sep 2019.
- Individual participant dataSharing planned: No
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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.
Norbert NIGHOGHOSSIAN principal investigator
Hospices Civils de Lyon
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 Diagnosis of TIA and MRI, run by Hospices Civils de Lyon at 1 site in France.
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 5 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 30 Sep 2019. 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 France. 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?
stroke recurrence within 90 days, (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Sep 2019.