Prevalence of Genetic Polymporphism on RNF213 rs112735431... | NCT02720861

Studies
Prevalence of Genetic Polymporphism on RNF213 rs112735431 Gene in Non-cardioemboli Ischemic Cerebrovascular Disease

NCT02720861

Sponsor

Chulalongkorn University

Status

Unknown status

Last Update Posted

Mar 28, 2016Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Ischemic Stroke

Interventions

DNA sequencing

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2015

Primary Completion Date

Mar 2016Actual

Completion Date

Jun 2016Estimated

First Submitted Date

Mar 15, 2016

First Submission Date that Met QC Criteria

Mar 25, 2016

First Posted Date

Mar 28, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2016

Last Update Posted Date

Mar 28, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Suporn Travanichakul, MD., Neurology Division of Chulalongkorn hospital, Chulalongkorn UniversityPrincipal Investigator

Lead Sponsor

Chulalongkorn UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To explore the prevalence of genetic polymorphism on RNF213 rs112735431 gene in non-cardioembolic ischemic cerebrovascular disease in Thai patients.

Detailed Description

This is an cross-sectional observational study in Chulalongkorn hospital, to determine the prevalence of genetic polymorphism on RNF213 rs112735431 gene in non-cardioembolic ischemic cerebrovascular disease. Patients who are potentially eligible for study participation will be identified through a chart review of patients who were admitted in Chulalongkorn Hospital for acute ischemic stroke treatment.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
non embolic ischemic stroke		acute ischemic stroke from atherosclerosis or lacunar stroke	Genetic: DNA sequencing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DNA sequencing	Genetic	withdraw 3m blood from vein only once during the whole design to analyse on DNA sequencing on RNF213 rs112735431 Gene	non embolic ischemic stroke

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With RNF213 rs112735431 Gene polymorphism		1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Nationality in Thailand
Age equal or more than 18 years
Clinical and imaging diagnosis of acute ischemic stroke
Patient consent to participate in the research

Exclusion Criteria:

High risk for cardioembolic stroke by TOAST classification
Contraindication for venipuncture
Pregnancy or breast feeding patient
History of head and neck radiation
Down's syndrome
Marfan syndrome
Autoimmune disease such as SLE
Ongoing malignancy or remission of malignancy less than 1year

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Acute ischemic stroke patients of Chulalongkorn hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Suporn Travanichakul, MD	Contact	0858054513		stravanichakul@yahoo.com

Overall Officials

Name	Affiliation	Role
Suporn Travanichakul, MD	Chulalongkorn University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Suporn Travanichakul	Recruiting	Bangkok	Bangkok	10330	Thailand

IPD Sharing Statement Module

Plan to Share IPD

Description

Not Share

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000083242	Ischemic Stroke

Ancestor Terms

ID	Term
D020521	Stroke
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017422	Sequence Analysis, DNA

Ancestor Terms

ID	Term
D017421	Sequence Analysis
D005821	Genetic Techniques
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided