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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04126434
Other study ID # WeiHuang19
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 10, 2019
Est. completion date December 31, 2022

Study information

Verified date September 2021
Source Peking University
Contact Wei Huang, PhD
Phone +86-13521966787
Email whuang@bjmu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: 1. Non-smoker of any type during past six months and living in a non-smoking household. 2. A diagnosis of myocardial infarction or unstable angina 7-90 days prior to signed informed consent. Exclusion Criteria: 1. Unstable CV disorders including uncompensated heart failure, refractory angina, uncontrolled arrhythmias, critical valvular heart disease and severe hypertension. 2. A history of infection with human immunodeficiency virus. 3. 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. 4. Pregnancy or intent to get pregnant during the study period.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
mask
facemask

Locations

Country Name City State
China Peking University ,School of Public Health Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

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