Intervention of Air Pollution and Acute Coronary Syndrome

September 14, 2021 updated by: WeiHuang, Peking University
To determine the effect of intervention of ambient air pollution on acute coronary syndrome patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Recruiting
        • Peking University ,School of Public Health
        • Contact:
        • Principal Investigator:
          • Wei Huang, PHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: no masking
not wearing facemask
Device: mask
facemask
Active Comparator: masking
wearing facemask
Device: mask
facemask

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University

Investigators

  • Principal Investigator: Wei Huang, PhD, Peking University Health Science Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2019

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

October 11, 2019

First Submitted That Met QC Criteria

October 11, 2019

First Posted (Actual)

October 15, 2019

Study Record Updates

Last Update Posted (Actual)

September 16, 2021

Last Update Submitted That Met QC Criteria

September 14, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WeiHuang19

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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