Intervention of Air Pollution and Acute Coronary Syndrome

Sponsor
Peking University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04126434
Collaborator
(none)
200
1
2
44.7
4.5

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: mask
N/A

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated 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 :
Apr 10, 2019
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Sham Comparator: no masking

not wearing facemask

Device: mask
facemask

Active Comparator: masking

wearing facemask

Device: mask
facemask

Outcome Measures

Primary Outcome Measures

  1. vascular function [six months]

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

  2. autonomic nervous function [six months]

    Twenty four-hour electrocardiograms and heart rate variability

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking University ,School of Public Health Beijing Beijing China 100191

Sponsors and Collaborators

  • Peking University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
WeiHuang, Principal Investigator, Peking University
ClinicalTrials.gov Identifier:
NCT04126434
Other Study ID Numbers:
  • WeiHuang19
First Posted:
Oct 15, 2019
Last Update Posted:
Sep 16, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 16, 2021