Air PollutionASPIRENCT03744871
Air Pollution: Strategies for Personalized Intervention to Reduce Exposure
A study testing N95 Respirator in people with Air Pollution, run by University Hospitals Cleveland Medical Center at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Air Pollution
- What is being tested?
- N95 Respirator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 22 Mar 2019to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
- -
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
About this study
Official title: ASPIRE: Air Pollution: Strategies for Personalized Intervention to Reduce Exposure
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.
Read the detailed description
CLEANAIR-ACS will be an investigation within ASPIRE, that will test the ability of personal-level intervention (N95 respirators) 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.
- Conditions
- Air Pollution
- Being tested
- N95 Respirator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N95 RespiratorOther
SiTi N95 respirator with microventilator (change twice weekly and earlier as needed).
| Study group | Role | What they receive |
|---|---|---|
| Respirator | Active comparator | Open label use of N95 respirators (worn outdoors) (active limb, n=100) Receives: Other: N95 Respirator |
| No intervention | No intervention | No respirators will be worn by the control group (control limb, n=100) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (2)
PWV and pulse wave analysis
To be measured at clinic visits, with Omron used in JI Study
Measured: 12 months
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start22 Mar 2019
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Air PollutionStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan, Peking University
- Responsible party
- Principal investigator, Sanjay Rajagopalan, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03744871
- Sponsor's protocol ID
- 03-18-20
- Other IDs
- R01ES019616
- Acronym
- ASPIRE
- Status last verified
- Dec 2023
- First submitted
- 27 Apr 2018
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASPIRE: Air Pollution: Strategies for Personalized Intervention to Reduce Exposure
- ClinicalTrials.gov ID
- NCT03744871
- Acronym / sponsor ID
- ASPIRE / 03-18-20
- Conditions
- Air Pollution
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- University of Michigan, Peking University
- Study start
- 22 Mar 2019 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 16 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
CLEANAIR-ACS will be an investigation within ASPIRE, that will test the ability of personal-level intervention (N95 respirators) 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Respirator | Active comparator | Other: N95 RespiratorOpen label use of N95 respirators (worn outdoors) (active limb, n=100) |
| No intervention | No intervention | –No respirators will be worn by the control group (control limb, n=100) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N95 RespiratorSiTi N95 respirator with microventilator (change twice weekly and earlier as needed). | Other | Respirator |
Primary outcome
Blood Pressure
Time frame: 12 months
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
2 secondary outcomes
PWV and pulse wave analysis
Time frame: 12 months
BP/HRV Monitoring
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing N95 Respirator in people with Air Pollution, run by University Hospitals Cleveland Medical Center at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2023.