Pulmonary HypertensionNCT03974919
Preoperative Pulmonary Systolic Pressure and Outcome After Non-cardiac Surgery:Threshold Analysis
An observational study of Pulmonary Hypertension, run by Peking University First Hospital at 1 site in China.
Trial summary
The linear or nonlinear relationship of pulmonary systolic pressure and cardiovascular and kidney outcome after non-cardiac surgery is unknown. This study is to explore the relationship of the two and try to identify the possible threshold of pulmonary systolic pressure for major cardio-vascular events after… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension
- How many people
- 19,000 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2019to 11 Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: non-cardiac surgery adult patients with preoperative echocardiography
Who may be able to join
- non-cardiac surgery patients with preoperative echocardiography records
Who cannot join
- electronic records missing or peri-operative data missing
Trial locations and contacts
1 site in 1 country.
China1 site
First hospital Peking University
Beijing, Beijing Municipality, 100034
About this study
Official title: Preoperative Pulmonary Systolic Pressure and Outcome After Non-Cardiac Surgery:Threshold Analysis
The linear or nonlinear relationship of pulmonary systolic pressure and cardiovascular and kidney outcome after non-cardiac surgery is unknown. This study is to explore the relationship of the two and try to identify the possible threshold of pulmonary systolic pressure for major cardio-vascular events after non-cardiac surgery.
Read the detailed description
The linear or nonlinear relationship of pulmonary systolic pressure and cardiovascular and kidney outcome after non-cardiac surgery is unknown. This study is to explore the relationship of the two and try to identify the possible threshold of pulmonary systolic pressure for major cardio-vascular events after non-cardiac surgery.
Patients with preoperative cardio-echogram under going non-cardiac surgery were collected. The postoperative major cardiovascular, cerebral and kidney events were also identified and collected. Other data including peri-operative information and surgeries and anesthesia data were gathered.
Logistic regression models were built and selected. Independent risk factors relative to postoperative major cardiovascular and cerebral events were screened and identified. Odds ratio, relative risk and relative risk ratio of varies dichomitus cut points were calculated, trend breakpoint were identified, propensity score analysis were also done for causal inference.
- Conditions
- Pulmonary Hypertension
- Being tested
- NO intervention required
- Keywords
- Pulmonary Hypertension, major cardiovascular event, non-cardiac surgery,threshold
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NO intervention requiredOther
NO intervention required
What is being measured
The primary outcome is the main question the study is designed to answer.
major adverse events
cardiac infarction, heart failure, cardiac death, stroke, acute kidney injury
Measured: 30 days postoperatively in hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start1 May 2019
- Primary completion10 Jun 2019
- Study completion11 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by Peking University First 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 19,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan Zhou, MD, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03974919
- Sponsor's protocol ID
- MAEPSP
- Status last verified
- Jul 2019
- First submitted
- 3 Jun 2019
- Last updated
- 9 Jul 2019
- 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 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Pulmonary Systolic Pressure and Outcome After Non-Cardiac Surgery:Threshold Analysis
- ClinicalTrials.gov ID
- NCT03974919
- Acronym / sponsor ID
- MAEPSP
- Conditions
- Pulmonary Hypertension
- Keywords
- Pulmonary Hypertension, major cardiovascular event, non-cardiac surgery,threshold
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19,000 participants (actual)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 10 Jun 2019 (actual)
- Study completion
- 11 Jun 2019 (actual)
- First posted
- 5 Jun 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.
The linear or nonlinear relationship of pulmonary systolic pressure and cardiovascular and kidney outcome after non-cardiac surgery is unknown. This study is to explore the relationship of the two and try to identify the possible threshold of pulmonary systolic pressure for major cardio-vascular events after non-cardiac surgery.
Detailed description
The linear or nonlinear relationship of pulmonary systolic pressure and cardiovascular and kidney outcome after non-cardiac surgery is unknown. This study is to explore the relationship of the two and try to identify the possible threshold of pulmonary systolic pressure for major cardio-vascular events after non-cardiac surgery.
Patients with preoperative cardio-echogram under going non-cardiac surgery were collected. The postoperative major cardiovascular, cerebral and kidney events were also identified and collected. Other data including peri-operative information and surgeries and anesthesia data were gathered.
Logistic regression models were built and selected. Independent risk factors relative to postoperative major cardiovascular and cerebral events were screened and identified. Odds ratio, relative risk and relative risk ratio of varies dichomitus cut points were calculated, trend breakpoint were identified, propensity score analysis were also done for causal inference.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- non-cardiac surgery adult patients with preoperative echocardiography
Key inclusion criteria (1 listed)
- non-cardiac surgery patients with preoperative echocardiography records
Key exclusion criteria (1 listed)
- electronic records missing or peri-operative data missing
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 |
|---|---|---|
| NO intervention requiredNO intervention required | Other | – |
Primary outcome
major adverse events
Time frame: 30 days postoperatively in hospital
cardiac infarction, heart failure, cardiac death, stroke, acute kidney injury
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 9 Jul 2019.
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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 Pulmonary Hypertension, run by Peking University First 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 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 9 Jul 2019. 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?
major adverse events (time frame: 30 days postoperatively in hospital). 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 9 Jul 2019.