Intervention of Air Pollution and Acute Coronary Syndrome

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

Study Overview

• Status: Recruiting
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Device: mask

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

• Study Contact: Name: Wei Huang, PHD; Phone Number: +86-13521966787; Email: whuang@bjmu.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Recruiting
      • Peking University ,School of Public Health
      • Contact: Wei Huang, PHD; Phone Number: +86-13521966787; Email: whuang@bjmu.edu.cn
      • Principal Investigator: Wei Huang, PHD

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	Systolic blood pressure and diastolic blood pressure measured by omron HBP-1300	six months
autonomic nervous function	Twenty four-hour electrocardiograms and heart rate variability	six months

Collaborators and Investigators

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

Study record dates

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: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome
• 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