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Intervention of Air Pollution and Acute Coronary Syndrome

Primary Purpose

Acute Coronary Syndrome

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

mask

About this trial

This is an interventional prevention trial for Acute Coronary Syndrome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Peking University ,School of Public HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

no masking

masking

Arm Description

not wearing facemask

wearing facemask

Outcomes

Primary Outcome Measures

vascular function

Systolic blood pressure and diastolic blood pressure measured by omron HBP-1300

autonomic nervous function

Twenty four-hour electrocardiograms and heart rate variability

Secondary Outcome Measures

Full Information

NCT ID

NCT04126434

First Posted

October 11, 2019

Last Updated

September 14, 2021

Sponsor

Peking University

1. Study Identification

Unique Protocol Identification Number

NCT04126434

Brief Title

Intervention of Air Pollution and Acute Coronary Syndrome

Official Title

Intervention of Air Pollution and Acute Coronary Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Unknown status

Study Start Date

April 10, 2019 (Actual)

Primary Completion Date

December 31, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Coronary Syndrome

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

no masking

Arm Type

Sham Comparator

Arm Description

not wearing facemask

Arm Title

masking

Arm Type

Active Comparator

Arm Description

wearing facemask

Intervention Type

Device

Intervention Name(s)

mask

Intervention Description

facemask

Primary Outcome Measure Information:

Title

vascular function

Description

Systolic blood pressure and diastolic blood pressure measured by omron HBP-1300

Time Frame

six months

Title

autonomic nervous function

Description

Twenty four-hour electrocardiograms and heart rate variability

Time Frame

six months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wei Huang, PhD

Phone

+86-13521966787

whuang@bjmu.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wei Huang, PhD

Organizational Affiliation

Peking University Health Science Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Peking University ,School of Public Health

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100191

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wei Huang, PHD

Phone

+86-13521966787

whuang@bjmu.edu.cn

First Name & Middle Initial & Last Name & Degree

Wei Huang, PHD

12. IPD Sharing Statement

Learn more about this trial

Intervention of Air Pollution and Acute Coronary Syndrome

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