Air Pollution: Strategies for Personalized Intervention to Reduce Exposure

NCT03744871 | Completed DMC

• 2 other identifiers: 03-18-20R01ES019616
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 2

Brief Summary

Fine particulate matter \< 2.5 microns (PM2.5) air pollution is a leading global risk factor for cardiovascular morbidity and mortality. PM2.5 presents a serious ongoing public health threat to patients living in highly-polluted countries (ex: China, India) where air quality is projected to remain extremely poor (far exceeding World Health Organization Air Quality Guidelines) for the foreseeable future. This study reviews the benefits of personal level intervention (wearing N95 respirator) over long term, to prevent clinical events among patients with cardiovascular disease.

Conditions

Air Pollution

Outcome Measures

Primary Outcomes (1)

• Blood Pressure

  Use Omron 907xl for clinic BP Measures, with 3 repeated measurements after 5 minutes after clinicians leave room (patient unattended). Averages of the 3 BP Recordings will be obtained

  12 months

Secondary Outcomes (2)

• PWV and pulse wave analysis

  12 months

• BP/HRV Monitoring

  12 months

Study Arms (2)

Respirator

ACTIVE COMPARATOR

Open label use of N95 respirators (worn outdoors) (active limb, n=100)

Other: N95 Respirator

No intervention

NO INTERVENTION

No respirators will be worn by the control group (control limb, n=100)

Interventions

N95 Respirator OTHER

SiTi N95 respirator with microventilator (change twice weekly and earlier as needed).

Respirator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female \>18, able to provide informed consent and willingness to complete the study protocol and measurement procedures, AND
• Non-smoker of any type (cigarette, cigar, marijuana) during past six months (100% abstinence per self-report) and living in a non-smoking household (no person living in the household smoking at home) with confirmation of non-smoking status by urinary cotinine levels.
• AND 3. A diagnosis of myocardial infarction or unstable angina 7-90 days prior to signed informed consent

You may not qualify if:

• Inability for mental or physical reasons to understand and comply with the informed consent process and/or the study protocol procedures including wearing face mask (i.e: advanced COPD/lung disease requiring use of frequent inhalational or nebulizer treatments) per investigator discretion.
• Obesity with arm circumference \>18 inches preventing accurate BP determination during ABPM monitoring
• Significant hemodynamically unstable CV disorder including uncompensated heart failure, refractory angina, uncontrolled arrhythmias, critical valvular heart disease and severe hypertension. (as further described in Appendix B) at screening
• ESRD on dialysis or patients that have received dialysis within 14 days prior to screening
• Subject has a history of infection with human immunodeficiency virus
• Subject has a history of alcohol or substance abuse within the 6 months prior to the screening
• Advanced COPD on home oxygen
• Past diagnosis of sleep apnea either untreated or treated with CPAP
• History of malignancy including leukemia and lymphoma (but not basal cell skin cancer, cured squamous cell cancer and localized Prostate cancer) AND/OR any severe, life-threatening disease AND/OR history of drug abuse within the last 2 years
• Regular use of any over-the-counter drug, recreational medication including stimulants (amphetamines) and/or complimentary or herbal therapy that might impact study outcomes including BP and insulin sensitivity per investigator discretion.
• In women of childbearing age: pregnancy, non-use of approved method of birth control, intent to get pregnant during the study period
• Patients with passive home cigarette smoking
• Other medical or psychosocial conditions or life circumstances that may put the subject at increased risk of participation or jeopardizes the scientific integrity of the study, as determined by the investigators

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• University of Michigan: collaborator
• Peking University: collaborator

Study Sites (2)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Peking University

Beijing, China

Location

MeSH Terms

Interventions

N95 Respirators

Intervention Hierarchy (Ancestors)

Surgical Attire; Equipment and Supplies, Hospital; Equipment and Supplies; Respiratory Protective Devices; Personal Protective Equipment; Protective Devices; Surgical Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Chief, Cardiovascular Medicine

Study Record Dates

• First Submitted: April 27, 2018
• First Posted: November 16, 2018
• Study Start: March 22, 2019
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: December 4, 2023

Record last verified: 2023-12

Locations

CN (1); US (1)