Clinical trial NCT05491824: Bio-Repository of DNA in Stroke: an Epidemiological and Genetic Study
Official title: Bio-Repository of DNA in Stroke: an Epidemiological and Genetic Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Stroke, Ischemic
Stroke Hemorrhagic
Lead sponsor: Royal Holloway University
Sponsor class: OTHER
First posted: 2022-08-08
Enrollment: 7500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.


Eligibility criteria: Cases

Inclusion Criteria:

* 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.

Exclusion Criteria:

* Unable to provide consent themselves or through surrogate.
* Stroke not defined on CT or MRI.

Controls

Inclusion Criteria:

* Patients should be aged \> 18 years at the time of enrolment.
* No previous history of stroke.
* able to provide written consent.

Primary outcomes:
measure: DNA repository of highly phenotyped stroke patients
timeFrame: 5 years
measure: Identify novel gene loci associated with different types of stroke
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College London
Study officials:
affiliation: Royal Holloway University
name: Pankaj Sharma, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: