Air Pollution and Cardiovascular Disease | NCT02573103

Studies
Air Pollution and Cardiovascular Disease

NCT02573103

Sponsor

WeiHuang

Status

Completed

Last Update Posted

Jul 12, 2018Actual

Enrollment

73Actual

Phase

Not provided

Conditions

Metabolic Disorder

Interventions

Not provided

Countries

Not provided

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

Jul 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

Nov 2014

Primary Completion Date

Jan 2016Actual

Completion Date

Jan 2016Actual

First Submitted Date

Sep 28, 2015

First Submission Date that Met QC Criteria

Oct 7, 2015

First Posted Date

Oct 9, 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

Jul 10, 2018

Last Update Posted Date

Jul 12, 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

To determine the effects of ambient airpollution exposures on cardiovascular responses among healthy adults without cardiovascular disease.

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

73Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dyslipidemia	Analyzed HDL by Beckman AU5800	One year

Secondary Outcomes

Measure	Description	Time Frame
System oxidative stress	Analyzed oxidative stress biomarkers,such as MDA by HPLC	One year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

without CV disease or risk factors (e.g., hypertension, diabetes, or treated hyperlipidemia). Subjects are non-smokers in non-smoking household.

Exclusion Criteria:

Screening visit BP>140/90 mm Hg, fasting glucose >126 mg/dL, or positive urine pregnancy test (females). Subjects cannot be taking any medications or over-the-counter drugs that affect CV function.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

We will maintain enrollment criteria of the in-progress study being healthy adults without CV disease or risk factors

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

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008659	Metabolic Diseases

Ancestor Terms

ID	Term
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided