StrokeBRAINSNCT05491824
Bio-Repository of DNA in Stroke: an Epidemiological and Genetic Study
An observational study of Stroke and Stroke, Ischemic, run by Royal Holloway University at 1 site in United Kingdom.
Trial summary
The Bio-Repository of DNA in Stroke (BRAINS) recruits all subtypes of stroke as well as controls from two different continents, Europe and Asia. Subjects recruited from the United Kingdom (UK) will include stroke patients of European ancestry as well as British South Asians. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Stroke, Ischemic, Stroke Hemorrhagic
- How many people
- 7,500 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Jun 2005to 31 Dec 2023
- 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: Patients and spouse or age-matched controls will be screened at the participating clinical centres in the United Kingdom (London, Luton, Birmingham, Leeds, Leicester, Airedale, Bradford, Wolverhampton and Blackburn), India (New Delhi and Kerala), Qatar and Sri Lanka (Colombo). Detailed phenotype data will be collected in a specially designed BRAINS data collection form. Stroke will be confirmed with computed tomography or magnetic resonance imaging and subtyped according to the Trial of ORG10172 in Acute Stroke Treatment (TOAST) classification. Baseline clinical and demographic data will also be collected. Blood samples will be collected in EDTA coated plastic serological tubes from all consenting patients and controls by means of a single venepuncture and DNA extracted from peripheral lymphocytes using standard procedure and stored at -20°C. Following genotyping the genetic data will be merged with phenotype data (environmental risk factors, stroke sub-type) for analysis.
Who may be able to join
- Patients should be aged > 18 years at the time of enrolment.
- Diagnosis of haemorrhagic or ischemic stroke using World Health Organization guidelines confirmed by clinical examination and imaging (CT or MRI).
- All patients with cerebral arteriovascular malformations and aneurysms.
- South Asian or Caucasian ethnic backgrounds.
- Patient or relative written informed consent.
- Patients should be aged > 18 years at the time of enrolment.
- No previous history of stroke.
- able to provide written consent.
Who cannot join
- Unable to provide consent themselves or through surrogate.
- Stroke not defined on CT or MRI.
- Controls
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Imperial College London
London, SW7 2BX
Pankaj Sharma, MD PhD
About this study
The Bio-Repository of DNA in Stroke (BRAINS) recruits all subtypes of stroke as well as controls from two different continents, Europe and Asia. Subjects recruited from the United Kingdom (UK) will include stroke patients of European ancestry as well as British South Asians. Stroke subjects from South Asia will be recruited from India and Sri Lanka. Subjects are also recruited in Qatar. South Asian cases will also have control subjects recruited.
- Conditions
- Stroke, Stroke, Ischemic, Stroke Hemorrhagic
- Medical subject headings
- Stroke, Ischemic Stroke, Hemorrhagic 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 |
|---|---|---|
| Stroke | Not described | |
| Non-stroke | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
DNA repository of highly phenotyped stroke patients
Measured: 5 years
Identify novel gene loci associated with different types of stroke
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start11 Jun 2005
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (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 StrokeStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 7,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Holloway University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pankaj Sharma, MD PhD, Royal Holloway University
- Investigators
- Pankaj Sharma, MD PhD, Principal investigator, Royal Holloway University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05491824
- Sponsor's protocol ID
- BRAINS
- Acronym
- BRAINS
- Status last verified
- Aug 2022
- First submitted
- 2 Aug 2022
- Last updated
- 8 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ken-Dror G, Sureshkumar P, Han TS, Sharma SD, Sylaja PN, Khan FY, Prasad K, Sharma P; BRAINS collaborators. Ischemic heart disease among South Asians with ischaemic stroke in three countries across two continents: the BRAINS study. Ann Epidemiol. 2025 Mar;103:48-54. doi: 10.1016/j.annepidem.2025.02.006. Epub 2025 Feb 19.
PubMed 39983852
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bio-Repository of DNA in Stroke: an Epidemiological and Genetic Study
- ClinicalTrials.gov ID
- NCT05491824
- Acronym / sponsor ID
- BRAINS / BRAINS
- Conditions
- Stroke, Stroke, Ischemic, Stroke Hemorrhagic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 7,500 participants (estimated)
- Lead sponsor
- Royal Holloway UniversityUniversity, hospital or other
- Study start
- 11 Jun 2005 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 8 Aug 2022 (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 Bio-Repository of DNA in Stroke (BRAINS) recruits all subtypes of stroke as well as controls from two different continents, Europe and Asia. Subjects recruited from the United Kingdom (UK) will include stroke patients of European ancestry as well as British South Asians. Stroke subjects from South Asia will be recruited from India and Sri Lanka. Subjects are also recruited in Qatar. South Asian cases will also have control subjects recruited.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke | – | – |
| Non-stroke | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients and spouse or age-matched controls will be screened at the participating clinical centres in the United Kingdom (London, Luton, Birmingham, Leeds, Leicester, Airedale, Bradford, Wolverhampton and Blackburn), India (New Delhi and Kerala), Qatar and Sri Lanka (Colombo). Detailed phenotype data will be collected in a specially designed BRAINS data collection form. Stroke will be confirmed with computed tomography or magnetic resonance imaging and subtyped according to the Trial of ORG10172 in Acute Stroke Treatment (TOAST) classification. Baseline clinical and demographic data will also be collected. Blood samples will be collected in EDTA coated plastic serological tubes from all consenting patients and controls by means of a single venepuncture and DNA extracted from peripheral lymphocytes using standard procedure and stored at -20°C. Following genotyping the genetic data will be merged with phenotype data (environmental risk factors, stroke sub-type) for analysis.
Key inclusion criteria (8 listed)
- Patients should be aged > 18 years at the time of enrolment.
- Diagnosis of haemorrhagic or ischemic stroke using World Health Organization guidelines confirmed by clinical examination and imaging (CT or MRI).
- All patients with cerebral arteriovascular malformations and aneurysms.
- South Asian or Caucasian ethnic backgrounds.
- Patient or relative written informed consent.
Key exclusion criteria (3 listed)
- Unable to provide consent themselves or through surrogate.
- Stroke not defined on CT or MRI.
- Controls
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
DNA repository of highly phenotyped stroke patients
Time frame: 5 years
Identify novel gene loci associated with different types of stroke
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2022.
- Derived from this study: PubMed 39983852Ken-Dror G, Sureshkumar P, Han TS, Sharma SD, Sylaja PN, Khan FY, Prasad K, Sharma P; BRAINS collaborators. Ischemic heart disease among South Asians with ischaemic stroke in three countries across two continents: the BRAINS study. Ann Epidemiol. 2025 Mar;103:48-54. doi: 10.1016/j.annepidem.2025.02.006. Epub 2025 Feb 19.
Related trials for 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
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Pankaj Sharma, MD PhD principal investigator
Royal Holloway University
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 Stroke and Stroke, Ischemic, run by Royal Holloway University at 1 site in United Kingdom.
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 8 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 8 Aug 2022. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pankaj Sharma, MD PhD (01784434455, Pankaj.Sharma@rhul.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DNA repository of highly phenotyped stroke patients (time frame: 5 years). The study lists 2 primary outcomes in all. 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 NCT05491824, 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 8 Aug 2022.