Air Pollution Clinical Trial
— ASPIREOfficial title:
ASPIRE: Air Pollution: Strategies for Personalized Intervention to Reduce Exposure
Verified date | December 2023 |
Source | University Hospitals Cleveland Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | July 31, 2023 |
Est. primary completion date | July 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Male or female >18, able to provide informed consent and willingness to complete the study protocol and measurement procedures, AND 2. 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 Exclusion Criteria: 1. 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. 2. Obesity with arm circumference >18 inches preventing accurate BP determination during ABPM monitoring 3. 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 4. ESRD on dialysis or patients that have received dialysis within 14 days prior to screening 5. Subject has a history of infection with human immunodeficiency virus 6. Subject has a history of alcohol or substance abuse within the 6 months prior to the screening 7. Advanced COPD on home oxygen 8. Past diagnosis of sleep apnea either untreated or treated with CPAP 9. 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 10. 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. 11. In women of childbearing age: pregnancy, non-use of approved method of birth control, intent to get pregnant during the study period 12. Patients with passive home cigarette smoking 13. 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 - |
Country | Name | City | State |
---|---|---|---|
China | Peking University | Beijing | |
United States | University Hospitals Cleveland Medical Center | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
University Hospitals Cleveland Medical Center | Peking University, University of Michigan |
United States, China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | PWV and pulse wave analysis | To be measured at clinic visits, with Omron used in JI Study | 12 months | |
Secondary | BP/HRV Monitoring | 24 hour ambulatory HRV/BP will be placed when clinic BP is complete as the first clinic measure. The monitoring systems have been used in JI study previously | 12 months |
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