Silent StrokeCBI-RegistryNCT05685069
Prevalence of Attributable Etiology and Modifiable Stroke Risk Factors in Patients With Covert Brain Infarctions
An observational study of Silent Stroke and Silent Cerebral Infarct, run by Insel Gruppe AG, University Hospital Bern at 2 sites in 2 countries.
Trial summary
The CBI registry is a prospective, interdisciplinary, multimodal observational registry of patients with covert brain infarction. Methods: A standardized workup in analogy to manifest ischemic stroke including cerebral MRI, long-term rhythm monitoring (3 x 7 days ECG), echocardiography, laboratory work-up and risk… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Silent Stroke, Silent Cerebral Infarct, Covert Brain Infarct
- How many people
- 230 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Mar 2019to 31 Aug 2026
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients will be recruited by the Neuroradiology Department of Inselspital Bern. All patients undergoing a brain MRI showing a presumably silent brain lesion and fulfilling the inclusion/exclusion criteria will be eligible for the study. Inpatients will be contacted while on a ward and outpatients by telephone calls.
Who may be able to join
- Any clinically silent ischemic lesions of the brain parenchyma detected on neuroimaging defined according to established criteria as either:
- DWI positive lesions: Focus of restricted diffusion (high DWI signal and low ADC value) occurring in either white or gray matter, located in the cerebrum, cerebellum, or brain stem AND not satisfying the diagnostic criteria for MS OR
- Cavitatory Lesions: ≥ 3 mm in size that follow CSF on all sequences that are slit or wedge shaped with an irregular margin AND NOT longitudinally aligned with perforating vessels or with a multiple, bilateral symmetrical distribution OR
- T2W hyperintense/T1W hypointense lesions: Focal lesion with high T2W signal and low T1W signal that have prior evidence of restricted diffusion; OR present within cortical gray matter or deep gray matter nuclei OR a lesion that is new, compared with an MRI performed within 3 months OR T2W hyper/T1W hypointense lesions in the white matter, which are discontinuous but associated with the classic confluent periventricular T2 intense change of leukoaraiosis (Fazekas ≥2) AND NOT satisfying the diagnostic criteria for MS or with a significant patient history of severe trauma, radiation, drug toxicity, or carbon monoxide poisoning
- Informed Consent as documented by signature by patient or legally authorized representative
Who cannot join
- Projected life expectancy of less than 2 years,
- Contraindication to MRI,
- Patients with a history of symptoms compatible with an AIS/TIA attributable to the lesion observed, covert neurological deficits are allowed,
- Patient is already included in another clinical trial that will affect the objectives of this study,
- Patient's lack of accountability, inability to appreciate the nature, meaning and consequences of the study and to formulate his/her own wishes correspondingly,
- Women who are pregnant or breast feeding or intention to become pregnant during the course of the study,
Show all 9Show fewer
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
- Contraindications to any of the routine procedures, e.g. inability to obtain neurovascular ultrasound examination,
- Known or suspected non-compliance, drug or alcohol abuse
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire de Tours
Tours
Marco Pasi
Switzerland1 site, 1 recruiting
- Recruiting
Inselspital Bern
Bern
Thomas Meinel, Dr. med., thomas.meinel@insel.ch
About this study
Official title: Prevalence of Attributable Etiology and Modifiable Stroke Risk Factors in Patients With Covert Brain Infarctions (CBI-registry)
The CBI registry is a prospective, interdisciplinary, multimodal observational registry of patients with covert brain infarction. Methods: A standardized workup in analogy to manifest ischemic stroke including cerebral MRI, long-term rhythm monitoring (3 x 7 days ECG), echocardiography, laboratory work-up and risk factor assessment as well as noninvasive angiography of the cervical and intracranial arteries will be performed.
Read the detailed description
Background: Covert brain infarction (CBI) are incidental lesions of presumably vascular etiology, detected on cerebral imaging and without attributable event of an acute ischemic stroke (AIS). Formerly thought to be completely "silent", CBI do have consequences: patients with CBI have a two-fold increased risk of severe stroke in the future, more often covert neurological deficits, and a steeper decline in cognitive function with increased risk of dementia. Important associations of CBI are described with hypertension, carotid stenosis, chronic kidney disease and metabolic syndrome, heart failure, coronary artery disease, hyperhomocysteinemia and obstructive sleep apnea. No trustworthy guidelines exist how to approach a patient with CBI.
Aim and hypothesis: The investigators want to provide a reliable estimate on the yield and relevance of a complete stroke workup to identify modifiable vascular risk factors in patients with CBI searching for an easily treatable cause of the event like a carotid stenosis, atrial fibrillation, hypertension or diabetes. The investigators' hypothesis is that a complete workup in patients with CBI has a similar yield of underlying pathological findings as compared to workup recommended for AIS.
Design: The SILENT registry is a prospective, interdisciplinary, multimodal observational registry of 230 patients with CBI. Methods: A standardized workup procedures including cerebral MRI, long-term rhythm monitoring (3 x 7 days ECG), echocardiography and noninvasive angiography of the cervical and intracranial arteries will be performed.
Statistics: A sample size calculation estimated a sample size of 230 patients. A prespecified analysis protocol will be used.
Significance: This study has the potential to extend the work-up of stroke to patients with CBI. Since CBI are up to three times more frequent than manifest ischemic stroke, this would have huge implications for primary stroke prevention.
- Conditions
- Silent Stroke, Silent Cerebral Infarct, Covert Brain Infarct, Covert Brain Infarction, Lacune, Silent Brain Infarction
- Keywords
- Covert brain infarction, Covert cerebrovascular disease, Ischemic stroke
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Standardized work-up | A standardized workup procedures including cerebral MRI, long-term rhythm monitoring (3 x 7 days ECG), echocardiography, stroke laboratory, risk factor assessment and noninvasive angiography of the cervical and intracranial arteries will be performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Modified Trial of Org 10172 in Acute Stroke Treatment etiology
Incorporating results from the baseline work-up the most likely etiology according to the modified Trial of Org 10172 in Acute Stroke Treatment (TOAST) for the chronic brain lesions observed will be rated:
- Large vessel atherothrombotic stroke: >=50% ipsilateral vascular stenosis present
- Cardiac embolism: Sustained or paroxysmal atrial fibrillation or atrial flutter and/or Structural or functional high-risk source of embolism
- Small vessel (lacunar) stroke: ischemia in perforating brain artery without embolic source
- Patent foramen ovale (PFO): PFO with or without atrial septal aneurysm with recommendation for closure (patient age <60 OR patient age 60-70 and Risk of Paradoxical Embolism (RoPE) Score ≥5
- Other specific etiology (e.g. dissections)
- Stroke of undetermined etiology (two or more causes identified, negative evaluation)
Measured: After baseline work-up, expected to be at least 3 months after brain imaging
Secondary outcomes (19)
Percentage of Modified Trial of Org 10172 in Acute Stroke Treatment etiology
Incorporating results from the baseline work-up the most likely etiology according to the modified Trial of Org 10172 in Acute Stroke Treatment (TOAST) for the chronic brain lesions observed will be rated:
- Large vessel atherothrombotic stroke: >=50% ipsilateral vascular stenosis present
- Cardiac embolism: Sustained or paroxysmal atrial fibrillation or atrial flutter and/or Structural or functional high-risk source of embolism
- Small vessel (lacunar) stroke: ischemia in perforating brain artery without embolic source
- Patent foramen ovale (PFO): PFO with or without atrial septal aneurysm with recommendation for closure (patient age <60 OR patient age 60-70 and Risk of Paradoxical Embolism (RoPE) Score ≥5
- Other specific etiology (e.g. dissections)
- Stroke of undetermined etiology (two or more causes identified, negative evaluation)
Measured: At the end of follow-up (2 years)
Median of National Institute of Health Stroke score (NIHSS)
The NIHSS is a 15-item neurological examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities, without coaching and without making assumptions about what the patient can do.
Ratings for each item are scored on a 3- to 5-point scale, with 0 as normal, and there is an allowance for untestable items. Scores range from 0 to 42, with higher scores indicating greater severity.
Measured: At baseline visit, expected to be at least 3 months after brain imaging
Percentage of Presence of covert neurological deficits corresponding to the CBI
Unrecognized or unreported stroke-like symptoms, called covert symptoms, e.g. visual field defect or slight ataxia
Measured: At baseline visit, expected to be at least 3 months after brain imaging
Median of Modified Rankin Scale functional status (mRS)
The Modified Rankin Scale (mRS) assesses disability in patients who have suffered a stroke and is compared over time to check for recovery and degree of continued disability. A score of 0 is no disability, 5 is disability requiring constant care for all needs; 6 is death.
Measured: At baseline visit, expected to be at least 3 months after brain imaging
Median of Montreal Cognitive Assessment (MOCA)
The Montreal Cognitive Assessment (MoCA) was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The MoCA may be administered by anyone who understands and follows the instructions, however, only a health professional with expertise in the cognitive field may interpret the results. Time to administer the MoCA is approximately 10 minutes. The total possible score is 30 points; a score of 26 or above is considered normal.
Measured: At baseline visit, expected to be at least 3 months after brain imaging
Median of Becks-Depression-Inventar-II
The Beck Depression Inventory (BDI, BDI-1A, BDI-II), created by Aaron T. Beck, is a 21-question multiple-choice self-report inventory. Like the BDI, the BDI-II also contains about 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms. The standardized cutoffs used differ from the original:
0-13: minimal depression 14-19: mild depression 20-28: moderate depression 29-63: severe depression.
Measured: At baseline visit, expected to be at least 3 months after brain imaging
Median of EuroQol-5d
The EQ-5D consists of several components: On the one hand, the self-assessment using the EQ-5D questionnaire, which describes the state of health using five dimensions:
Agility, mobility the ability to take care of yourself Everyday activities (e.g. work, studies, housework, family, free time) pain, physical discomfort fear, depression
Measured: At baseline visit, expected to be at least 3 months after brain imaging
Number of Participants with Dyslipidemia
according to the 2018 ACC/AHA recommendations
Measured: After baseline work-up, expected to be at least 3 months after brain imaging
Number of Participants with New diagnosis of diabetes mellitus type 2
Elevated HbA1c or random glucose according to the 2017 International Diabetes Federation Guidelines
Measured: After baseline work-up, expected to be at least 3 months after brain imaging
Number of Participants with Hematological abnormality
requiring change of management
Measured: After baseline work-up, expected to be at least 3 months after brain imaging
Number of Participants with Abnormality in renal function or electrolytes
requiring change of management
Measured: After baseline work-up, expected to be at least 3 months after brain imaging
Number of Participants with Ischemic stroke
defined as new sudden focal neurological deficit of presumed cerebrovascular etiology, occurring > 24 hours after the index SBI, that persisted beyond 24 hours and was not due to another identifiable cause
Measured: At the end of follow-up (2 years)
Number of Participants with TIA
defined as a transient episode of neurologic dysfunction caused by focal brain, spinal cord, or retinal ischemia without cerebral infarction on imaging
Measured: At the end of follow-up (2 years)
Number of Participants with Myocardial infarction
defined as typical symptoms and cardiac biomarker elevation (troponin I or T, creatine kinase-MB) above the upper limit of normal, new pathological Q waves in at least 2 contiguous electrocardiogram leads, or confirmation at autopsy or by coronary angiography or by MRI.
Measured: At the end of follow-up (2 years)
Number of Participants with relevant symptomatic intracranial hemorrhage
including subdural, epidural, subarachnoidal and intracerebral hemorrhage, defined as hemorrhage that leads to a clinical worsening and hospitalisation and is assessed by the treating physician to be likely the cause of the new neurological symptom or the death. Intracerebral hemorrhage due to a trauma will not be considered.
Measured: At the end of follow-up (2 years)
Number of Participants with Major cardiovascular events
defined as composite of stroke, myocardial infarct, heart failure or cardiovascular death)
Measured: At the end of follow-up (2 years)
Number of Participants with Systemic embolism
defined as abrupt vascular insufficiency associated with clinical or radiological evidence of arterial occlusion of an extremity or organ in absence of another likely mechanism (e.g. atherosclerosis, instrumentation or trauma)
Measured: At the end of follow-up (2 years)
Number of Participants with Vascular death
defined as death that is due to a vascular cause
Measured: At the end of follow-up (2 years)
Number of Participants with All-cause mortality
defined as death of any cause
Measured: At the end of follow-up (2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start1 Mar 2019
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Aug 2026 (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 Silent StrokeStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urs Fischer, Prof. Dr. med., Principal investigator, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05685069
- Sponsor's protocol ID
- 2019-00293
- Other IDs
- 2019
- Acronym
- CBI-Registry
- Status last verified
- Nov 2024
- First submitted
- 21 Dec 2022
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Open to expand the registry to other centers. Can provide the materials:
Publications
Meinel TR, Kaesmacher J, Roten L, Fischer U. Covert Brain Infarction: Towards Precision Medicine in Research, Diagnosis, and Therapy for a Silent Pandemic. Stroke. 2020 Aug;51(8):2597-2606. doi: 10.1161/STROKEAHA.120.030686. Epub 2020 Jul 10. No abstract available.
PubMed 32646332
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Attributable Etiology and Modifiable Stroke Risk Factors in Patients With Covert Brain Infarctions (CBI-registry)
- ClinicalTrials.gov ID
- NCT05685069
- Acronym / sponsor ID
- CBI-Registry / 2019-00293
- Conditions
- Silent Stroke, Silent Cerebral Infarct, Covert Brain Infarct, Covert Brain Infarction, Lacune, Silent Brain Infarction
- Keywords
- Covert brain infarction, Covert cerebrovascular disease, Ischemic stroke
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 13 Jan 2023 (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.
The CBI registry is a prospective, interdisciplinary, multimodal observational registry of patients with covert brain infarction. Methods: A standardized workup in analogy to manifest ischemic stroke including cerebral MRI, long-term rhythm monitoring (3 x 7 days ECG), echocardiography, laboratory work-up and risk factor assessment as well as noninvasive angiography of the cervical and intracranial arteries will be performed.
Detailed description
Background: Covert brain infarction (CBI) are incidental lesions of presumably vascular etiology, detected on cerebral imaging and without attributable event of an acute ischemic stroke (AIS). Formerly thought to be completely "silent", CBI do have consequences: patients with CBI have a two-fold increased risk of severe stroke in the future, more often covert neurological deficits, and a steeper decline in cognitive function with increased risk of dementia. Important associations of CBI are described with hypertension, carotid stenosis, chronic kidney disease and metabolic syndrome, heart failure, coronary artery disease, hyperhomocysteinemia and obstructive sleep apnea. No trustworthy guidelines exist how to approach a patient with CBI.
Aim and hypothesis: The investigators want to provide a reliable estimate on the yield and relevance of a complete stroke workup to identify modifiable vascular risk factors in patients with CBI searching for an easily treatable cause of the event like a carotid stenosis, atrial fibrillation, hypertension or diabetes. The investigators' hypothesis is that a complete workup in patients with CBI has a similar yield of underlying pathological findings as compared to workup recommended for AIS.
Design: The SILENT registry is a prospective, interdisciplinary, multimodal observational registry of 230 patients with CBI. Methods: A standardized workup procedures including cerebral MRI, long-term rhythm monitoring (3 x 7 days ECG), echocardiography and noninvasive angiography of the cervical and intracranial arteries will be performed.
Statistics: A sample size calculation estimated a sample size of 230 patients. A prespecified analysis protocol will be used.
Significance: This study has the potential to extend the work-up of stroke to patients with CBI. Since CBI are up to three times more frequent than manifest ischemic stroke, this would have huge implications for primary stroke prevention.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standardized work-up | – | –A standardized workup procedures including cerebral MRI, long-term rhythm monitoring (3 x 7 days ECG), echocardiography, stroke laboratory, risk factor assessment and noninvasive angiography of the cervical and intracranial arteries will be performed. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients will be recruited by the Neuroradiology Department of Inselspital Bern. All patients undergoing a brain MRI showing a presumably silent brain lesion and fulfilling the inclusion/exclusion criteria will be eligible for the study. Inpatients will be contacted while on a ward and outpatients by telephone calls.
Key inclusion criteria (5 listed)
- Any clinically silent ischemic lesions of the brain parenchyma detected on neuroimaging defined according to established criteria as either:
- Informed Consent as documented by signature by patient or legally authorized representative
Key exclusion criteria (9 listed)
- Projected life expectancy of less than 2 years,
- Contraindication to MRI,
- Patients with a history of symptoms compatible with an AIS/TIA attributable to the lesion observed, covert neurological deficits are allowed,
- Patient is already included in another clinical trial that will affect the objectives of this study,
- Patient's lack of accountability, inability to appreciate the nature, meaning and consequences of the study and to formulate his/her own wishes correspondingly,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Modified Trial of Org 10172 in Acute Stroke Treatment etiology
Time frame: After baseline work-up, expected to be at least 3 months after brain imaging
Incorporating results from the baseline work-up the most likely etiology according to the modified Trial of Org 10172 in Acute Stroke Treatment (TOAST) for the chronic brain lesions observed will be rated: * Large vessel atherothrombotic stroke: >=50% ipsilateral vascular stenosis present * Cardiac embolism: Sustained or paroxysmal atrial fibrillation or atrial flutter and/or Structural or functional high-risk source of embolism * Small vessel (lacunar) stroke: ischemia in perforating brain artery without embolic source * Patent foramen ovale (PFO): PFO with or without atrial septal aneurysm with recommendation for closure (patient age <60 OR patient age 60-70 and Risk of Paradoxical Embolism (RoPE) Score ≥5 * Other specific etiology (e.g. dissections) * Stroke of undetermined etiology (two or more causes identified, negative evaluation)
19 secondary outcomes
Percentage of Modified Trial of Org 10172 in Acute Stroke Treatment etiology
Time frame: At the end of follow-up (2 years)
Median of National Institute of Health Stroke score (NIHSS)
Time frame: At baseline visit, expected to be at least 3 months after brain imaging
Percentage of Presence of covert neurological deficits corresponding to the CBI
Time frame: At baseline visit, expected to be at least 3 months after brain imaging
Median of Modified Rankin Scale functional status (mRS)
Time frame: At baseline visit, expected to be at least 3 months after brain imaging
Median of Montreal Cognitive Assessment (MOCA)
Time frame: At baseline visit, expected to be at least 3 months after brain imaging
Median of Becks-Depression-Inventar-II
Time frame: At baseline visit, expected to be at least 3 months after brain imaging
Median of EuroQol-5d
Time frame: At baseline visit, expected to be at least 3 months after brain imaging
Number of Participants with Dyslipidemia
Time frame: After baseline work-up, expected to be at least 3 months after brain imaging
Number of Participants with New diagnosis of diabetes mellitus type 2
Time frame: After baseline work-up, expected to be at least 3 months after brain imaging
Number of Participants with Hematological abnormality
Time frame: After baseline work-up, expected to be at least 3 months after brain imaging
Number of Participants with Abnormality in renal function or electrolytes
Time frame: After baseline work-up, expected to be at least 3 months after brain imaging
Number of Participants with Ischemic stroke
Time frame: At the end of follow-up (2 years)
Number of Participants with TIA
Time frame: At the end of follow-up (2 years)
Number of Participants with Myocardial infarction
Time frame: At the end of follow-up (2 years)
Number of Participants with relevant symptomatic intracranial hemorrhage
Time frame: At the end of follow-up (2 years)
Number of Participants with Major cardiovascular events
Time frame: At the end of follow-up (2 years)
Number of Participants with Systemic embolism
Time frame: At the end of follow-up (2 years)
Number of Participants with Vascular death
Time frame: At the end of follow-up (2 years)
Number of Participants with All-cause mortality
Time frame: At the end of follow-up (2 years)
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 14 Nov 2024.
- Background: PubMed 32646332Meinel TR, Kaesmacher J, Roten L, Fischer U. Covert Brain Infarction: Towards Precision Medicine in Research, Diagnosis, and Therapy for a Silent Pandemic. Stroke. 2020 Aug;51(8):2597-2606. doi: 10.1161/STROKEAHA.120.030686. Epub 2020 Jul 10. No abstract available.
- Substudy offering implantable cardiac monitors to patients with CBI and high risk for atrial fibrillationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Open to expand the registry to other centers. Can provide the materials:
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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.
Urs Fischer, Prof. Dr. med. principal investigator
Insel Gruppe AG, University Hospital Bern
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Silent Stroke and Silent Cerebral Infarct, run by Insel Gruppe AG, University Hospital Bern at 2 sites in 2 countries.
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 9 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 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, Switzerland. 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 Urs Fischer, Prof. Dr. med. (+41 31 63 2 33 79, urs.fischer@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Modified Trial of Org 10172 in Acute Stroke Treatment etiology (time frame: After baseline work-up, expected to be at least 3 months after brain imaging). 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 NCT05685069, 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 14 Nov 2024.