Pulmonary EmbolismNCT04419194
Effect of Climatic Factors on the Seasonal Fluctuation of Pulmonary Embolism
An observational study of Pulmonary Embolism, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
To estimate the risks of daily hospital admissions for pulmonary embolism associated with short term exposure to climatic factors (temperature, precipitation, air pressure, sunshine duration, relative humidity, wind speed, and ambient fine particulate matter [aerodynamic diameter ≤2.5 μm; PM2.5]) in China. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Embolism
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 31 Jul 2014to 31 Jul 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed as pulmonary embolism who meet the inclusion criteria above.
Who may be able to join
- Males and females.
- With a primary diagnosis of pulmonary embolism based on clinical symptoms, with or without radiologic features.
Who cannot join
- Lack of important data.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: Association Between Climatic Factors and Hospital Admissions for Pulmonary Embolism: Time Series Study in China Between Years 2014 to 2019.
To estimate the risks of daily hospital admissions for pulmonary embolism associated with short term exposure to climatic factors (temperature, precipitation, air pressure, sunshine duration, relative humidity, wind speed, and ambient fine particulate matter [aerodynamic diameter ≤2.5 μm; PM2.5]) in China.
Read the detailed description
Hospital admissions for pulmonary embolism were identified based on the primary diagnosis. The central adjudication committee at Peking Union Medical College Hospital (Beijing, China) reviewed all medical and death records and determined the final diagnosis. Two adjudication committee members verified events independently, and discrepancies were resolved by discussion involving additional committee members.For each admission, we extracted data on the date of admission, sex, age, and location of the patient from hospital information system.
All the data of daily meteorological variables for the same period, including temperature variables (°C) (the min, max and mean temperature), relative humidity (%), air pressure (hPa), precipitation (mm), wind speed (m/s) and sunshine duration (h), were collected from the China Meteorological Data Sharing Service System (http://www.escience.gov.cn/metdata/page/index.html). The data on PM2.5 levels in each city was collected from the National Air Pollution Monitoring System.
An overdispersed generalised additive model was used to estimate associations between climatic factors and pulmonary embolism admissions. A distributed lag non-linear model (DLNM) was employed to examine their lagged effects.
- Conditions
- Pulmonary Embolism
- Keywords
- Pulmonary Embolism, Climate
- Medical subject headings
- Pulmonary Embolism
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 |
|---|---|---|
| Observation | Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of pulmonary embolism
Daily counts of hospital admissions for primary diagnoses of pulmonary embolism among different demographic groups were used to estimate the associations between climatic factors and morbidity.
Measured: From July 31, 2014 to July 31, 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start31 Jul 2014
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shi Juhong, M.D, Study chair, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04419194
- Sponsor's protocol ID
- PUMCH-PE-Climatic factors
- Status last verified
- May 2020
- First submitted
- 4 Jun 2020
- Last updated
- 5 Jun 2020
- 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 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Climatic Factors and Hospital Admissions for Pulmonary Embolism: Time Series Study in China Between Years 2014 to 2019.
- ClinicalTrials.gov ID
- NCT04419194
- Acronym / sponsor ID
- PUMCH-PE-Climatic factors
- Conditions
- Pulmonary Embolism
- Keywords
- Pulmonary Embolism, Climate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 31 Jul 2014 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 5 Jun 2020 (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 estimate the risks of daily hospital admissions for pulmonary embolism associated with short term exposure to climatic factors (temperature, precipitation, air pressure, sunshine duration, relative humidity, wind speed, and ambient fine particulate matter [aerodynamic diameter ≤2.5 μm; PM2.5]) in China.
Detailed description
Hospital admissions for pulmonary embolism were identified based on the primary diagnosis. The central adjudication committee at Peking Union Medical College Hospital (Beijing, China) reviewed all medical and death records and determined the final diagnosis. Two adjudication committee members verified events independently, and discrepancies were resolved by discussion involving additional committee members.For each admission, we extracted data on the date of admission, sex, age, and location of the patient from hospital information system.
All the data of daily meteorological variables for the same period, including temperature variables (°C) (the min, max and mean temperature), relative humidity (%), air pressure (hPa), precipitation (mm), wind speed (m/s) and sunshine duration (h), were collected from the China Meteorological Data Sharing Service System (http://www.escience.gov.cn/metdata/page/index.html). The data on PM2.5 levels in each city was collected from the National Air Pollution Monitoring System.
An overdispersed generalised additive model was used to estimate associations between climatic factors and pulmonary embolism admissions. A distributed lag non-linear model (DLNM) was employed to examine their lagged effects.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation | – | –Observation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed as pulmonary embolism who meet the inclusion criteria above.
Key inclusion criteria (2 listed)
- Males and females.
- With a primary diagnosis of pulmonary embolism based on clinical symptoms, with or without radiologic features.
Key exclusion criteria (1 listed)
- Lack of important data.
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
Incidence of pulmonary embolism
Time frame: From July 31, 2014 to July 31, 2019
Daily counts of hospital admissions for primary diagnoses of pulmonary embolism among different demographic groups were used to estimate the associations between climatic factors and morbidity.
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 Jun 2020.
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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.
Shi Juhong, M.D study chair
Peking Union Medical College Hospital
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 Pulmonary Embolism, run by Peking Union Medical College Hospital 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 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 Jun 2020. 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?
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?
Incidence of pulmonary embolism (time frame: From July 31, 2014 to July 31, 2019). 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 Jun 2020.