A Comparison of the Estimates of Fuwai and Reynolds Risk... | NCT02241239

Studies
A Comparison of the Estimates of Fuwai and Reynolds Risk Model

NCT02241239

Sponsor

Wuhan Asia Heart Hospital

Status

Unknown status

Last Update Posted

Nov 6, 2014Estimated

Enrollment

500Estimated

Phase

Not provided

Conditions

Coronary Heart Disease and 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

Aug 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

Aug 2014

Primary Completion Date

Dec 2014Estimated

Completion Date

Dec 2014Estimated

First Submitted Date

Aug 31, 2014

First Submission Date that Met QC Criteria

Sep 15, 2014

First Posted Date

Sep 16, 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

Nov 5, 2014

Last Update Posted Date

Nov 6, 2014Estimated

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

There are many risk prediction models. And their estimates are different. This study aimed to investigate the differences between the estimates of Fuwai and Reynolds risk model in Chinese, and investigate the reason for the differences.

Detailed Description

The participants will examined for cardiovascular risk factors, and their cardiovascular risks will be calculated based on the values of the risk factors using cardiovascular risk models. The estimates of different risk models will be compared, and the levels of traditional risk factors will be adjusted in order to evaluate the impacts of uncommon risk factors such as social and genetic risk factors.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
participants		healthy adults without stroke and coronary heart disease

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
cardiovascular risk	The cardiovascular risk is the probability of the occurrence of coronary heart disease and stroke. The cardiovascular risk is calculated by risk prediction models based on the patient's risk factors.	1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: adults -

Exclusion Criteria: with coronary heart disease

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

adults without coronary heart disease

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Youping Chen, M.D,	Contact	+86-27-65796888	8501	sageeeee@163.com

Overall Officials

Name	Affiliation	Role
Youping Chen, M.D.	Wuhan Asia Heart Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wuhan Asia Heart Hospital	Recruiting	Wuhan	Hubei	430000	China

Condition Browse Module

MeSH Terms

ID	Term
D003327	Coronary Disease
D020521	Stroke

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided