Air Pollution and Cardiometabolic Study | NCT02601352

Studies
Air Pollution and Cardiometabolic Study

NCT02601352

Sponsor

WeiHuang

Status

Completed

Last Update Posted

Apr 5, 2018Actual

Enrollment

45Actual

Phase

Not provided

Conditions

Cardiovascular Outcomes

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

Apr 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2015

Primary Completion Date

Jan 2016Actual

Completion Date

Jan 2016Actual

First Submitted Date

Nov 3, 2015

First Submission Date that Met QC Criteria

Nov 9, 2015

First Posted Date

Nov 10, 2015Estimated

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

Apr 3, 2018

Last Update Posted Date

Apr 5, 2018Actual

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

The study mainly focuse on examining the subjects living in traffic polluted area and assessing the popuation health risk using disease and risk assessment models.

Detailed Description

Not provided

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

Retention

Enrollment

45Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Vascular endothelial function	Vascular endothelial function measured by Endo-PAT2000	Four months
Arrythmias	Twenty four-hour electrocardiograms	Four months

Secondary Outcomes

Measure	Description	Time Frame
System inflammatory	Analyzed systemic inflammation biomarkers,such as C-reaction Protein and Blood coagulation by ELISA	Four months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Living in PU community neighborhood，Non smoker and No diseases ,and so on.

Exclusion Criteria:

Advanced microvascular or neuropathic complications and active cardiovascular disease,and so on.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Living in PU community neighborhood,Beijing, China

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wei Huang, PhD	Peking University School of Public Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University ,School of Public Health		Beijing	Beijing Municipality	100191	China
Peking University