Bio-Repository of DNA in Stroke: an Epidemiological and Genetic Study

NCT05491824 | Unknown

• 1 other identifier: BRAINS
• Study Type: observational
• Target: 7,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Stroke, Ischemic; Stroke Hemorrhagic

Outcome Measures

Primary Outcomes (2)

• DNA repository of highly phenotyped stroke patients

  5 years

• Identify novel gene loci associated with different types of stroke

  5 years

Study Arms (2)

Stroke

Non-stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Unable to provide consent themselves or through surrogate.
• Stroke not defined on CT or MRI.
• Controls
• Patients should be aged \> 18 years at the time of enrolment.
• No previous history of stroke.
• able to provide written consent.

Sponsors & Collaborators

• Royal Holloway University: lead

Study Sites (1)

Imperial College London

London, SW7 2BX, United Kingdom

RECRUITING

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Hemorrhagic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Pankaj Sharma, MD PhD

  Royal Holloway University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pankaj Sharma, MD PhD

CONTACT

01784434455; Pankaj.Sharma@rhul.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 8, 2022
• Study Start: June 11, 2005
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: August 8, 2022

Record last verified: 2022-08

Locations

GB (1)