Cardiovascular OutcomesNCT04125212
Air Pollution and Cardio-metabolic Health
An observational study of Cardiovascular Outcomes, run by Peking University at 1 site in China.
Trial summary
To investigate the effects of air pollution on surrogate cardio-metabolic outcomes in young healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Outcomes
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 21 Sep 2019to 1 Jun 2022
- Phase
- Observational
- 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 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: non-smoker young healthy adults
Who may be able to join
- Living in Peking University Health Science Center neighborhood.
- Non smoker and no diseases.
Who cannot join
- Advanced microvascular complications and active cardiovascular disease.
- Pregnancy or intent to get pregnant during the study period.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University ,School of Public Health
Beijing, Beijing Municipality, 100191
About this study
Official title: Effects of Air Pollution on Cardio-metabolic Outcomes Among Heathy Adults
To investigate the effects of air pollution on surrogate cardio-metabolic outcomes in young healthy adults.
Read the detailed description
To investigate the effects of air pollution on surrogate cardio-metabolic outcomes in a panel study involving young healthy adults living in Beijing, China with extreme high ambient air pollution levels.
- Conditions
- Cardiovascular Outcomes
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Systolic blood pressure and diastolic blood pressure
Measured: Four months
Secondary outcomes (1)
Systemic inflammatory
Systemic inflammation biomarkers, such as C-reactive protein etc.
Measured: Four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2019
- Study start21 Sep 2019
- Primary completion16 Jan 2020
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular OutcomesStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WeiHuang, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04125212
- Sponsor's protocol ID
- WeiHuang
- Status last verified
- Sep 2021
- First submitted
- 11 Oct 2019
- Last updated
- 16 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Air Pollution on Cardio-metabolic Outcomes Among Heathy Adults
- ClinicalTrials.gov ID
- NCT04125212
- Acronym / sponsor ID
- WeiHuang
- Conditions
- Cardiovascular Outcomes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 21 Sep 2019 (actual)
- Primary completion
- 16 Jan 2020 (actual)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 14 Oct 2019 (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.
To investigate the effects of air pollution on surrogate cardio-metabolic outcomes in young healthy adults.
Detailed description
To investigate the effects of air pollution on surrogate cardio-metabolic outcomes in a panel study involving young healthy adults living in Beijing, China with extreme high ambient air pollution levels.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- non-smoker young healthy adults
Key inclusion criteria (2 listed)
- Living in Peking University Health Science Center neighborhood.
- Non smoker and no diseases.
Key exclusion criteria (2 listed)
- Advanced microvascular complications and active cardiovascular disease.
- Pregnancy or intent to get pregnant during the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Blood pressure
Time frame: Four months
Systolic blood pressure and diastolic blood pressure
1 secondary outcome
Systemic inflammatory
Time frame: Four months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Outcomes, run by Peking University at 1 site in China.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
Results are not available in the source record.
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: Four 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 16 Sep 2021.