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

August 4, 2022 updated by: Pankaj Sharma, MD PhD, Royal Holloway University
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 Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

7500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • London, United Kingdom, SW7 2BX
        • Recruiting
        • Imperial College London
        • Contact:
          • Pankaj Sharma, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Stroke
Non-stroke

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
DNA repository of highly phenotyped stroke patients
Time Frame: 5 years
5 years
Identify novel gene loci associated with different types of stroke
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Holloway University

Investigators

  • Principal Investigator: Pankaj Sharma, MD PhD, Royal Holloway University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 11, 2005

Primary Completion (ANTICIPATED)

December 31, 2023

Study Completion (ANTICIPATED)

December 31, 2023

Study Registration Dates

First Submitted

August 2, 2022

First Submitted That Met QC Criteria

August 4, 2022

First Posted (ACTUAL)

August 8, 2022

Study Record Updates

Last Update Posted (ACTUAL)

August 8, 2022

Last Update Submitted That Met QC Criteria

August 4, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRAINS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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