China Atrial Fibrillation Screening in Acute Ischemic Str... | NCT02156765

Studies
China Atrial Fibrillation Screening in Acute Ischemic Stroke Patients

NCT02156765

Sponsor

yongjun wang

Status

Unknown status

Last Update Posted

Jun 5, 2014Estimated

Enrollment

3,000Estimated

Phase

Not provided

Conditions

Atrial Fibrillation
Stroke

Interventions

Not provided

Countries

China

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

Jun 2014

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

Oct 2013

Primary Completion Date

Mar 2015Estimated

Completion Date

Mar 2015Estimated

First Submitted Date

Jun 3, 2014

First Submission Date that Met QC Criteria

Jun 4, 2014

First Posted Date

Jun 5, 2014Estimated

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

Jun 4, 2014

Last Update Posted Date

Jun 5, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

yongjun wang, vice president of Tiantan Hospital, Ministry of Science and Technology of the People´s Republic of ChinaSponsor-Investigator

Lead Sponsor

yongjun wangOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Three purpose of this study:

Increase diagnosis rate and formulate the flow of diagnosis and treatment of AF in ischemic stroke patients;
Evaluation on specificity and sensitivity of STAF score;
Analyze the pathogenesis of ischemic stroke and risk factors and establish clinical database and sample database of ischemic stroke.

Detailed Description

Inclusion criteria:

Hospitalized patients with ischemic stroke that are diagnosed definitely;
Age ≥ 18 years;
Within 7 days after the onset of diseases;
Signed the consent informed form.

Exclusion criteria:

Patients with noncerebrovascular diseases that are diagnosed definitely;
Silent cerebral infarction (CI) without symptoms and signs;
Those refuse to sign the consent informed form of the study.

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

6 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Accumulated detection rate of AF	ECG was monitored for all patients enrolled in a single center for consecutive 6 days	1.5 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hospitalized patients with ischemic stroke that are diagnosed definitely;
Age ≥ 18 years;
Within 7 days after the onset of diseases;
Signed the consent informed form.

Exclusion Criteria:

Patients with noncerebrovascular diseases that are diagnosed definitely;
Silent cerebral infarction (CI) without symptoms and signs;
Those refuse to sign the consent informed form of the study.

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

Hospitalized patients with ischemic stroke that are diagnosed definitely

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
yongjun wang, doctor	Contact	13911172565		yongjunwang1962@gmail.com

Overall Officials

Name	Affiliation	Role
yongjun wang, doctor	Tiantan Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Stroke Association	Recruiting	Beijing	Beijing Municipality	100050	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16240340	Background	Ay H, Furie KL, Singhal A, Smith WS, Sorensen AG, Koroshetz WJ. An evidence-based causative classification system for acute ischemic stroke. Ann Neurol. 2005 Nov;58(5):688-97. doi: 10.1002/ana.20617.
31403970	Derived	Li SY, Yang XM, Zhao XQ, Liu LP, Wang YL, Jiang Y, Wang YJ. Newly detected atrial fibrillation is associated with cortex-involved ischemic stroke. Chin Med J (Engl). 2019 Sep 5;132(17):2053-2058. doi: 10.1097/CM9.0000000000000390.

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes