Air Pollution: Strategies for Personalized Intervention to Reduce Exposure

CLEANAIR-ACS will be an investigation within ASPIRE, that will test the ability of
personal-level intervention (N95 respirators combined with nasal cyclones) to improve
validated surrogate markers of cardio-metabolic health in patients with a recent Acute
Coronary Syndrome (ACS). Patients with ACS are a vulnerable patient population with
vulnerability and at risk for future cardiovascular events. This vanguard phase study in
Beijing involving patients exposed to high levels of air pollution who have recently
sustained an ACS event, is necessary to obtain feasibility data and gather a battery of
information allowing for the appropriate design of a larger clinical outcome trial. What is
more, positive results would provide critically-important information demonstrating for the
first time that it is feasible to "prescribe" the use of these personal protection devices to
cardiac patients, and that their usage is capable of translating into demonstrable health
benefits (i.e., improved BP and insulin sensitivity) over the long-term.

The study hypothesis is that long-term personal-level interventions to reduce exposure to
PM2.5 can be feasibly performed for 1-year post-acute coronary syndrome (ACS) and will result
in significant improvements in validated surrogate cardiometabolic endpoints predictive of
morbidity/mortality.

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