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Intervention of Air Pollution and Acute Coronary Syndrome

P

Peking University

Status

Unknown

Conditions

Acute Coronary Syndrome

Treatments

Device: mask

Study type

Interventional

Funder types

Other

Identifiers

NCT04126434
WeiHuang19

Details and patient eligibility

About

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

Full description

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

Enrollment

200 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 2 patient groups

no masking
Sham Comparator group
Description:
not wearing facemask
Treatment:
Device: mask
masking
Active Comparator group
Description:
wearing facemask
Treatment:
Device: mask

Trial contacts and locations

1

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Central trial contact

Wei Huang, PhD

Data sourced from clinicaltrials.gov

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