Ischemic StrokeRELATENCT04620642
Lyon Registry of Stroke Treated by Thrombolysis or Thrombectomy
An observational study of Ischemic Stroke, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
This observational study as an objective of characterizing the population of patients treated within the neurovascular unit of the Pierre Wertheimer hospital (Hospices Civils de Lyon) in order to determine their phenotype (age, sex, risk factors, etc.) and its evolution over time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Registry
- How many people
- 4,500 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2020to Mar 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 over 18 years old, hospitalized in the neurovascular unit of the Pierre Wertheimer Neurological Hospital (Hospices Civils de Lyon), for an ischemic stroke treated by thrombolysis and / or mechanical thrombectomy and not opposed to this research.
Who may be able to join
- - Patients over 18 years old,
- Hospitalization in the neurovascular unit of the Pierre Wertheimer Neurological Hospital (Hospices Civils de Lyon),
- Ischemic stroke treated by thrombolysis and / or mechanical thrombectomy.
Who cannot join
- - Opposition to this research.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Pierre Wertheimer, GHE, HCL
Lyon
Pr Tae-Hee CHO CHO, MD, 0033 4 72 35 78 07, tae-hee.cho@chu-lyon.fr
About this study
This observational study as an objective of characterizing the population of patients treated within the neurovascular unit of the Pierre Wertheimer hospital (Hospices Civils de Lyon) in order to determine their phenotype (age, sex, risk factors, etc.) and its evolution over time. It also aims to assess the management of ischemic stroke (IS) in the neurovascular unit of Pierre Wertheimer Hospital. We will assess in particular the pre-hospital and hospital care times, the type of medical care (thrombolysis and / or thrombectomy) as well as the efficiency of this care (effective recanalization, outcome of patient, etc.).
Read the detailed description
All patient who has had an IS with an indication of thrombolysis and / or thrombectomy, hospitalized in the neurovascular unit of Pierre Wertheimer Hospital (HCL) since January 2013 and until December 2030 will be contacted for this study
- Conditions
- Ischemic Stroke
- Being tested
- Registry
- Keywords
- Ischemic Stroke, revascularisation therapy, registry
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RegistryBiological
No specific intervention. Data of the usual care will be collected as the medical history, the demographic data, the biological analyses, imaging report, etc.
| Study group | Role | What they receive |
|---|---|---|
| Registry group | Patients over 18 years old, hospitalized in the neurovascular unit of the Pierre Wertheimer Neurological Hospital (Hospices Civils de Lyon), for an ischemic stroke treated by thrombolysis and / or mechanical thrombectomy and not opposed to this research Receives: Biological: Registry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phenotype of the population
Characterization the population of patients with stroke treated by thrombolysis and / or thrombectomy in the neurovascular unit of the Pierre Wertheimer Hospital, Hospices Civils de Lyon : age, sex, risk factors, becoming, etc.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start1 Aug 2020
- Primary completionMar 2031 (estimated)
- Study completionMar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies 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
- Prospective
- Enrolment
- 4,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04620642
- Sponsor's protocol ID
- 69HCL20_0924
- Acronym
- RELATE
- Status last verified
- Nov 2020
- First submitted
- 3 Nov 2020
- Last updated
- 9 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rascle L, Bani Sadr A, Amaz C, Mewton N, Buisson M, Hermier M, Ong E, Fontaine J, Derex L, Berthezene Y, Eker OF, Cho TH, Nighoghossian N, Mechtouff L. Does the Brush-Sign Reflect Collateral Status and DWI-ASPECTS in Large Vessel Occlusion? Front Neurol. 2022 Mar 2;13:828256. doi: 10.3389/fneur.2022.828256. eCollection 2022.
PubMed 35309551
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lyon Registry of Stroke Treated by Thrombolysis or Thrombectomy
- ClinicalTrials.gov ID
- NCT04620642
- Acronym / sponsor ID
- RELATE / 69HCL20_0924
- Conditions
- Ischemic Stroke
- Keywords
- Ischemic Stroke, revascularisation therapy, registry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,500 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- Mar 2031 (estimated)
- Study completion
- Mar 2031 (estimated)
- First posted
- 9 Nov 2020 (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.
This observational study as an objective of characterizing the population of patients treated within the neurovascular unit of the Pierre Wertheimer hospital (Hospices Civils de Lyon) in order to determine their phenotype (age, sex, risk factors, etc.) and its evolution over time. It also aims to assess the management of ischemic stroke (IS) in the neurovascular unit of Pierre Wertheimer Hospital. We will assess in particular the pre-hospital and hospital care times, the type of medical care (thrombolysis and / or thrombectomy) as well as the efficiency of this care (effective recanalization, outcome of patient, etc.).
Detailed description
All patient who has had an IS with an indication of thrombolysis and / or thrombectomy, hospitalized in the neurovascular unit of Pierre Wertheimer Hospital (HCL) since January 2013 and until December 2030 will be contacted for this study
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Registry group | – | Biological: RegistryPatients over 18 years old, hospitalized in the neurovascular unit of the Pierre Wertheimer Neurological Hospital (Hospices Civils de Lyon), for an ischemic stroke treated by thrombolysis and / or mechanical thrombectomy and not opposed to this research |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 18 years old, hospitalized in the neurovascular unit of the Pierre Wertheimer Neurological Hospital (Hospices Civils de Lyon), for an ischemic stroke treated by thrombolysis and / or mechanical thrombectomy and not opposed to this research.
Key inclusion criteria (3 listed)
- - Patients over 18 years old,
- Hospitalization in the neurovascular unit of the Pierre Wertheimer Neurological Hospital (Hospices Civils de Lyon),
- Ischemic stroke treated by thrombolysis and / or mechanical thrombectomy.
Key exclusion criteria (1 listed)
- - Opposition to this research.
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 |
|---|---|---|
| RegistryNo specific intervention. Data of the usual care will be collected as the medical history, the demographic data, the biological analyses, imaging report, etc. | Biological | Registry group |
Primary outcome
Phenotype of the population
Time frame: 3 months
Characterization the population of patients with stroke treated by thrombolysis and / or thrombectomy in the neurovascular unit of the Pierre Wertheimer Hospital, Hospices Civils de Lyon : age, sex, risk factors, becoming, etc.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
- Derived from this study: PubMed 35309551Rascle L, Bani Sadr A, Amaz C, Mewton N, Buisson M, Hermier M, Ong E, Fontaine J, Derex L, Berthezene Y, Eker OF, Cho TH, Nighoghossian N, Mechtouff L. Does the Brush-Sign Reflect Collateral Status and DWI-ASPECTS in Large Vessel Occlusion? Front Neurol. 2022 Mar 2;13:828256. doi: 10.3389/fneur.2022.828256. eCollection 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Ischemic Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Recruiting
Biomarkers of Paired VNS
Stroke, Ischemic
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.
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 Stroke, 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 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: looking for participants now, as of the sponsor's last update on 9 Nov 2020. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tae Hee CHO, MD (0033 4 72 35 78 07, tae-hee.cho@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phenotype of the population (time frame: 3 months). 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 NCT04620642, which also lists 1 linked publication.
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 9 Nov 2020.