Major Adverse Cardiovascular Events in Patients With Coronary Artery DiseaseNCT05550805
Prognostic Study of Major Adverse Cardiovascular Events in Patients With Coronary Artery Disease Based on Metabolomics, and Lipidomics (BIPass II)
An observational study of Major Adverse Cardiovascular Events in Patients With Coronary Artery Disease, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
To investigate whether there were differences in metabolomics and lipidomics in patients with coronary artery disease who had major adverse cardiovascular events during follow-up compared with those who did not. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Adverse Cardiovascular Events in Patients With Coronary Artery Disease
- How many people
- 5,822 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2017to 1 Mar 2022
- 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 coronary artery disease
Who may be able to join
- Hospitalized patients with the diagnosis of any type of coronary artery disease;
- Age ≥18 years of age;
- Patient or guardian provided informed written consent.
Who cannot join
- Prior surgery, trauma or clinically evident coagulopathic bleeding within the previous 2 weeks;
- Bipass population with missing follow-up records in Qilu Hospital emergency follow-up cohort.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prognostic Study of Major Adverse Cardiovascular Events in Patients With Coronary Artery Disease Based on Metabolomics, and Lipidomics
To investigate whether there were differences in metabolomics and lipidomics in patients with coronary artery disease who had major adverse cardiovascular events during follow-up compared with those who did not.
What is being measured
The primary outcome is the main question the study is designed to answer.
major adverse cardiovascular events
cardiac death, myocardial infarction, heart failure, stroke
Measured: 20191101-20220701
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start1 Nov 2017
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Adverse Cardiovascular Events in Patients With Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,822 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05550805
- Sponsor's protocol ID
- 20220914-Qilu
- Status last verified
- May 2025
- First submitted
- 20 Sep 2022
- Last updated
- 31 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Study of Major Adverse Cardiovascular Events in Patients With Coronary Artery Disease Based on Metabolomics, and Lipidomics
- ClinicalTrials.gov ID
- NCT05550805
- Acronym / sponsor ID
- 20220914-Qilu
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,822 participants (actual)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 22 Sep 2022 (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 investigate whether there were differences in metabolomics and lipidomics in patients with coronary artery disease who had major adverse cardiovascular events during follow-up compared with those who did not.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with coronary artery disease
Key inclusion criteria (3 listed)
- Hospitalized patients with the diagnosis of any type of coronary artery disease;
- Age ≥18 years of age;
- Patient or guardian provided informed written consent.
Key exclusion criteria (2 listed)
- Prior surgery, trauma or clinically evident coagulopathic bleeding within the previous 2 weeks;
- Bipass population with missing follow-up records in Qilu Hospital emergency follow-up cohort.
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
Time frame: 20191101-20220701
cardiac death, myocardial infarction, heart failure, stroke
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 31 May 2025.
- 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 Major Adverse Cardiovascular Events in Patients With Coronary Artery Disease, run by Qilu Hospital of Shandong 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 2 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 31 May 2025. 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 cardiovascular events (time frame: 20191101-20220701). 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 31 May 2025.