Cardiovascular OutcomesNCT02601352
Air Pollution and Cardiometabolic Study
An observational study of Cardiovascular Outcomes, run by WeiHuang at 2 sites in China.
Trial summary
The study mainly focuse on examining the subjects living in traffic polluted area and assessing the popuation health risk using disease and risk assessment models. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Outcomes
- How many people
- 45 participants
- Where
- 2 sitesChina
- Study dates
- Sep 2015to Jan 2016
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Living in PU community neighborhood,Beijing, China
Who may be able to join
- Living in PU community neighborhood，Non smoker and No diseases ,and so on.
Who cannot join
- Advanced microvascular or neuropathic complications and active cardiovascular disease,and so on.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Peking University ,School of Public Health
Beijing, Beijing Municipality, 100191
Peking University
Beijing, Beijing Municipality, 100191
About this study
Official title: Characterization and Health Risk Assessment of Exposure to Source-Specific PM2.5 in Subjects in Beijing
The study mainly focuse on examining the subjects living in traffic polluted area and assessing the popuation health risk using disease and risk assessment models.
- Conditions
- Cardiovascular Outcomes
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular endothelial function
Vascular endothelial function measured by Endo-PAT2000
Measured: Four months
Arrythmias
Twenty four-hour electrocardiograms
Measured: Four months
Secondary outcomes (1)
System inflammatory
Analyzed systemic inflammation biomarkers,such as C-reaction Protein and Blood coagulation by ELISA
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 posted10 Nov 2015 (estimated)
- Study startSep 2015
- Primary completionJan 2016
- Study completionJan 2016
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.
- 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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- WeiHuang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, WeiHuang, Peking University
- Investigators
- Wei Huang, PhD, Principal investigator, Peking University School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02601352
- Sponsor's protocol ID
- WHuang15_17
- Status last verified
- Apr 2018
- First submitted
- 3 Nov 2015
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization and Health Risk Assessment of Exposure to Source-Specific PM2.5 in Subjects in Beijing
- ClinicalTrials.gov ID
- NCT02601352
- Acronym / sponsor ID
- WHuang15_17
- Conditions
- Cardiovascular Outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- WeiHuangUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 10 Nov 2015 (estimated)
- 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.
The study mainly focuse on examining the subjects living in traffic polluted area and assessing the popuation health risk using disease and risk assessment models.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Living in PU community neighborhood,Beijing, China
Key inclusion criteria (1 listed)
- Living in PU community neighborhood，Non smoker and No diseases ,and so on.
Key exclusion criteria (1 listed)
- Advanced microvascular or neuropathic complications and active cardiovascular disease,and so on.
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
Vascular endothelial function
Time frame: Four months
Vascular endothelial function measured by Endo-PAT2000
Arrythmias
Time frame: Four months
Twenty four-hour electrocardiograms
1 secondary outcome
System inflammatory
Time frame: Four 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 5 Apr 2018.
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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.
Wei Huang, PhD principal investigator
Peking University School of Public Health
2 sites 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 WeiHuang at 2 sites 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 1 inclusion and 1 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 5 Apr 2018. 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 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?
Vascular endothelial function (time frame: Four months). The study lists 2 primary outcomes in all. 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 5 Apr 2018.