Lipid Metabolism DisordersNCT03344224
Pre-operative Blood Lipid Level and Post-operative Major Adverse Cardiac Event
An observational study of Lipid Metabolism Disorders and Postoperative Complications, run by Peking University First Hospital.
Trial summary
Whether the pre-operative blood lipid level and post-operative cardiovascular events is associated is unknown. This study is to find out the main blood lipid and relative protein level change and the post-operative cardiovascular events occurrence. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Lipid Metabolism Disorders, Postoperative Complications
- What is being tested?
- laboratory test
- How many people
- 50,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 20 Sep 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult non-cardiac surgery patients
Who may be able to join
- non-cardiac surgery patients with preoperative blood lipid tests
Who cannot join
- electronic records missing or peri-operative data missing
About this study
Official title: The Relationship of Pre-operative Blood Lipid Level and Post-operative Major Adverse Cardiac Event Occurence
Whether the pre-operative blood lipid level and post-operative cardiovascular events is associated is unknown. This study is to find out the main blood lipid and relative protein level change and the post-operative cardiovascular events occurrence.
Read the detailed description
The participants collected data from their hospital.Patients under going non-cardiac surgery were collected. Data of Triglycerides, cholesterol, Low-density lipoprotein and High-density lipoprotein were collected perioperatively. The postoperative major cardiovascular and cerebral events were also identified and collected. Other data including perioperative 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. different levels of Triglycerides, cholesterol, Low-density lipoprotein and High-density lipoprotein were analysed.
- Being tested
- laboratory test
- Medical subject headings
- Lipid Metabolism Disorders, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory testDiagnostic test
laboratory test
| Study group | Role | What they receive |
|---|---|---|
| normal blood lipid/protein group | Not described Receives: Diagnostic Test: laboratory test | |
| abnormal blood lipid/protein group | Not described Receives: Diagnostic Test: laboratory test |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiovascular events
such as acute myocardial infarction
Measured: 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start1 Jan 2017
- Primary completion30 Jul 2017
- Study completion20 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lipid Metabolism DisordersStudies 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
- 50,000 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
- NCT03344224
- Sponsor's protocol ID
- LMACE
- Status last verified
- Jan 2018
- First submitted
- 13 Nov 2017
- Last updated
- 4 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Leardi S, Altilia F, Delmonaco S, Cianca G, Pietroletti R, Simi M. [Blood levels of cholesterol and postoperative septic complications]. Ann Ital Chir. 2000 Mar-Apr;71(2):233-7. Italian.
PubMed 10920496
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship of Pre-operative Blood Lipid Level and Post-operative Major Adverse Cardiac Event Occurence
- ClinicalTrials.gov ID
- NCT03344224
- Acronym / sponsor ID
- LMACE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50,000 participants (actual)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Jul 2017 (actual)
- Study completion
- 20 Sep 2017 (actual)
- First posted
- 17 Nov 2017 (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.
Whether the pre-operative blood lipid level and post-operative cardiovascular events is associated is unknown. This study is to find out the main blood lipid and relative protein level change and the post-operative cardiovascular events occurrence.
Detailed description
The participants collected data from their hospital.Patients under going non-cardiac surgery were collected. Data of Triglycerides, cholesterol, Low-density lipoprotein and High-density lipoprotein were collected perioperatively. The postoperative major cardiovascular and cerebral events were also identified and collected. Other data including perioperative 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. different levels of Triglycerides, cholesterol, Low-density lipoprotein and High-density lipoprotein were analysed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal blood lipid/protein group | – | Diagnostic Test: laboratory test |
| abnormal blood lipid/protein group | – | Diagnostic Test: laboratory test |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult non-cardiac surgery patients
Key inclusion criteria (1 listed)
- non-cardiac surgery patients with preoperative blood lipid tests
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 |
|---|---|---|
| laboratory testlaboratory test | Diagnostic test | abnormal blood lipid/protein group, normal blood lipid/protein group |
Primary outcome
cardiovascular events
Time frame: 30 days postoperatively
such as acute myocardial infarction
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 4 Jan 2018.
- Background: PubMed 10920496Leardi S, Altilia F, Delmonaco S, Cianca G, Pietroletti R, Simi M. [Blood levels of cholesterol and postoperative septic complications]. Ann Ital Chir. 2000 Mar-Apr;71(2):233-7. Italian.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Lipid Metabolism Disorders and Postoperative Complications, run by Peking University First Hospital.
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 4 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
cardiovascular events (time frame: 30 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03344224, which also lists 1 linked publication.
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 4 Jan 2018.