Air PollutionNCT02652182
Short-term Air Pollution Exposure and In-hospital Outcomes in Patients With Acute Myocardial Infraction
An observational study of Air Pollution and Acute Myocardial Infarction, run by Nanjing Medical University at 1 site in China.
Trial summary
The aim of this study is to investigate whether or not short-term expose to air pollution is associated with in-hospital outcomes, such as mortality and morbidity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Air Pollution, Acute Myocardial Infarction, Percutaneous Coronary Intervention
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Jan 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with acute ST (S- and T-wave)-segment elevation myocardial infarction who received emergent percutaneous coronary intervention
Who may be able to join
- Less than 12 hours after the onset of myocardial infarction symptoms
- Documented acute ST (S- and T-wave)-segment elevation myocardial infarction
- Received emergent percutaneous coronary intervention
Who cannot join
- Age under 18-year old
Trial locations and contacts
1 site in 1 country.
China1 site
Huai'an First People's Hospital, Nanjing Medical University
Huai'an, Jiangsu, 223300
About this study
The aim of this study is to investigate whether or not short-term expose to air pollution is associated with in-hospital outcomes, such as mortality and morbidity.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | patients with acute ST (S- and T-wave)-segment elevation myocardial infarction who received emergent percutaneous coronary intervention in Huai'an first people's hospital | |
| 2 | patients with acute ST(S- and T-wave)-segment elevation myocardial infarction who received emergent percutaneous coronary intervention in Nanjing Drum Tower hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular events (MACE)
Measured: in the phase of hospital stay, up to 30 days
Secondary outcomes (3)
Length of hospital stay
Measured: in the phase of hospital stay, up to 30 days
ST (S- and T-wave) segment decreasing
Measured: within an hour after primary percutaneous coronary intervention
left ventricular function
left ventricular ejection fraction in % and left ventricular end-diastolic diameter in mm, both are evaluated by echocardiography to assess the left ventricular function
Measured: in the phase of hospital stay, up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2017 (estimated)
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 Nanjing Medical 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
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Geng, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02652182
- Sponsor's protocol ID
- 20160006
- Status last verified
- Jul 2016
- First submitted
- 6 Jan 2016
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Air Pollution Exposure and In-hospital Outcomes in Patients With Acute Myocardial Infraction
- ClinicalTrials.gov ID
- NCT02652182
- Acronym / sponsor ID
- 20160006
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Study start
- Jan 2016
- Primary completion
- Jan 2017 (estimated)
- First posted
- 11 Jan 2016 (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 aim of this study is to investigate whether or not short-term expose to air pollution is associated with in-hospital outcomes, such as mortality and morbidity.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –patients with acute ST (S- and T-wave)-segment elevation myocardial infarction who received emergent percutaneous coronary intervention in Huai'an first people's hospital |
| 2 | – | –patients with acute ST(S- and T-wave)-segment elevation myocardial infarction who received emergent percutaneous coronary intervention in Nanjing Drum Tower hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with acute ST (S- and T-wave)-segment elevation myocardial infarction who received emergent percutaneous coronary intervention
Key inclusion criteria (3 listed)
- Less than 12 hours after the onset of myocardial infarction symptoms
- Documented acute ST (S- and T-wave)-segment elevation myocardial infarction
- Received emergent percutaneous coronary intervention
Key exclusion criteria (1 listed)
- Age under 18-year old
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
Major adverse cardiovascular events (MACE)
Time frame: in the phase of hospital stay, up to 30 days
3 secondary outcomes
Length of hospital stay
Time frame: in the phase of hospital stay, up to 30 days
ST (S- and T-wave) segment decreasing
Time frame: within an hour after primary percutaneous coronary intervention
left ventricular function
Time frame: in the phase of hospital stay, up to 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
- Individual participant dataSharing planned: No
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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 Air Pollution and Acute Myocardial Infarction, run by Nanjing Medical 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 3 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: status not confirmed, as of the sponsor's last update on 26 Jul 2016. 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?
Major adverse cardiovascular events (MACE) (time frame: in the phase of hospital stay, up to 30 days). 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 26 Jul 2016.