NCT04126434

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 15, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

September 16, 2021

Status Verified

September 1, 2021

Enrollment Period

3.7 years

First QC Date

October 11, 2019

Last Update Submit

September 14, 2021

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

no masking

SHAM COMPARATOR

not wearing facemask

Device: mask

masking

ACTIVE COMPARATOR

wearing facemask

Device: mask

Interventions

maskDEVICE

facemask

maskingno masking

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non-smoker of any type during past six months and living in a non-smoking household.
  • A diagnosis of myocardial infarction or unstable angina 7-90 days prior to signed informed consent.

You may not qualify if:

  • Unstable CV disorders including uncompensated heart failure, refractory angina, uncontrolled arrhythmias, critical valvular heart disease and severe hypertension.
  • A history of infection with human immunodeficiency virus.
  • 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.
  • Pregnancy or intent to get pregnant during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University ,School of Public Health

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Masks

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Surgical AttireEquipment and Supplies, HospitalEquipment and SuppliesProtective DevicesPersonal Protective EquipmentSurgical EquipmentManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Wei Huang, PhD

    Peking University Health Science Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Huang, PhD

CONTACT

+86-13521966787whuang@bjmu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 11, 2019

First Posted

October 15, 2019

Study Start

April 10, 2019

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

September 16, 2021

Record last verified: 2021-09

Locations

CN(1)