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Intervention of Air Pollution and Acute Coronary Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04126434
Recruitment Status : Recruiting
First Posted : October 15, 2019
Last Update Posted : October 17, 2019
Information provided by (Responsible Party):
WeiHuang, Peking University

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

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Device: mask Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Intervention of Air Pollution and Acute Coronary Syndrome
Actual Study Start Date : April 10, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Air Pollution

Arm Intervention/treatment
Sham Comparator: no masking
not wearing facemask
Device: mask

Active Comparator: masking
wearing facemask
Device: mask

Primary Outcome Measures :
  1. vascular function [ Time Frame: six months ]
    Systolic blood pressure and diastolic blood pressure measured by omron HBP-1300

  2. autonomic nervous function [ Time Frame: six months ]
    Twenty four-hour electrocardiograms and heart rate variability

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04126434

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Contact: Wei Huang, PhD +86-13521966787

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China, Beijing
Peking University ,School of Public Health Recruiting
Beijing, Beijing, China, 100191
Contact: Wei Huang, PHD    +86-13521966787   
Principal Investigator: Wei Huang, PHD         
Sponsors and Collaborators
Peking University
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Principal Investigator: Wei Huang, PhD Peking University Health Science Center

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Responsible Party: WeiHuang, Principal Investigator, Peking University Identifier: NCT04126434    
Other Study ID Numbers: WeiHuang19
First Posted: October 15, 2019    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases