Intervention of Air Pollution and Acute Coronary Syndrome | NCT04126434

Studies
Intervention of Air Pollution and Acute Coronary Syndrome

NCT04126434

Sponsor

Peking University

Status

Unknown status

Last Update Posted

Sep 16, 2021Actual

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Acute Coronary Syndrome

Interventions

mask

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

Sep 2021

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

Apr 10, 2019Actual

Primary Completion Date

Dec 31, 2022Estimated

Completion Date

Dec 31, 2022Estimated

First Submitted Date

Oct 11, 2019

First Submission Date that Met QC Criteria

Oct 11, 2019

First Posted Date

Oct 15, 2019Actual

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

Sep 14, 2021

Last Update Posted Date

Sep 16, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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 effect of intervention of ambient air pollution on acute coronary syndrome patients.

Detailed Description

To investgate the effect of wearing facemasks to decreasing levels of exposure to ambient air on acute coronary syndrome patients.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
no masking	Sham Comparator	not wearing facemask	Device: mask
masking	Active Comparator	wearing facemask	Device: mask

Interventions

Name	Type	Description	Arm Group Labels	Other Names
mask	Device	facemask	masking no masking

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
vascular function	Systolic blood pressure and diastolic blood pressure measured by omron HBP-1300	six months
autonomic nervous function	Twenty four-hour electrocardiograms and heart rate variability	six months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Non-smoker of any type during past six months and living in a non-smoking household.
A diagnosis of myocardial infarction or unstable angina 7-90 days prior to signed informed consent.

Exclusion Criteria:

Unstable CV disorders including uncompensated heart failure, refractory angina, uncontrolled arrhythmias, critical valvular heart disease and severe hypertension.
A history of infection with human immunodeficiency virus.
History of malignancy including leukemia and lymphoma AND/OR any severe, life-threatening disease AND/OR history of drug abuse within the last 2 years.
Pregnancy or intent to get pregnant during the study period.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wei Huang, PhD	Contact	+86-13521966787		whuang@bjmu.edu.cn

Overall Officials

Name	Affiliation	Role
Wei Huang, PhD	Peking University Health Science Center	Principal Investigator

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D054058	Acute Coronary Syndrome

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008397	Masks

Ancestor Terms

ID	Term
D058257	Surgical Attire
D004865	Equipment and Supplies, Hospital
D004864	Equipment and Supplies
D011482	Protective Devices

Browse Leaves

Not provided

Browse Branches

Not provided