Lipid DisorderNCT05645367
Associations of Lipid Measures With Premature Myocardial Infarction: a Cross-sectional Study
An observational study of Lipid Disorder and Premature Myocardial Infarction, run by Yue LI at 1 site in China.
Trial summary
Acute myocardial infarction (AMI) is the first cardiovascular cause of death that seriously threatens human health worldwide. Its incidence rate and mortality are increasing year by year and becoming younger. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lipid Disorder, Premature Myocardial Infarction
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 30 Jun 2024
- How long will I take part?
- 1 Year
- 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: AMI patients who completed coronary angiography in the First Affiliated Hospital of Harbin Medical University from September 1, 2021 to September 31, 2022 were included consecutively to establish an AMI research queue. Baseline information such as demographic information, medical history information and laboratory examination results were collected through the electronic medical record system.
Who may be able to join
- According to the fourth Universal Definition of Myocardial Infarction (2018), the clinical diagnosis was acute myocardial infarction (AMI), including type 1, 2, 3, 4b and 4c.
- Complete coronary angiography
- Complete biochemical and blood lipid tests
Who cannot join
- Recurrent AMI
- The onset of AMI exceeds 7 days
- Continuous taking of lipid-lowering drugs ≥ 5 days
- Patients with missing data
Trial locations and contacts
1 site in 1 country.
China1 site
the first affiliated hospital of Harbin medical university
Harbin, Heilongjiang, 150001
About this study
Acute myocardial infarction (AMI) is the first cardiovascular cause of death that seriously threatens human health worldwide. Its incidence rate and mortality are increasing year by year and becoming younger. According to statistics, the average age of men and women with AMI for the first time is 65.6 years old and 72 years old respectively, of which 4%~10% AMI occurred before 45 years old. At present, there is no uniform age threshold for young AMI. Generally speaking, AMI with onset age less than 55 years for men and 65 years for women is called early-onset AMI, accounting for 5%~13% of AMI. Compared with elderly patients with AMI, patients with early onset AMI have different risk factors, clinical characteristics and prognosis, such as lower proportion of patients with diabetes and hypertension, more single vessel lesions and rare left main artery involvement, and higher long-term recurrence rate and mortality. Although the progress of preventive measures and treatment methods has reduced the hospitalization rate of elderly AMI patients, the number of young AMI patients in hospital is still rising. Therefore, in-depth analysis of the characteristics of risk factors of early onset AMI and early intervention are of great significance to reduce the risk of onset and improve long-term prognosis.
Hyperlipidemia is an independent risk factor for coronary heart disease at all ages, and is more closely related to early onset AMI. It is reported that more than 50% of early onset AMI patients are accompanied by hyperlipidemia. However, at present, the research on the relationship between blood lipids and early onset AMI is limited to the comparison of the level of single lipid component between early onset AMI and different control groups, or the comparative analysis of the relationship between a specific lipid component and the risk of early onset AMI with young healthy people. There is no research to compare the correlation between various lipid components and the risk of early onset AMI. Therefore, this study plans to deeply analyze the correlation between different blood lipid components and their ratios and early onset AMI, and further analyze which blood lipid indicators are most closely related to early onset AMI through large sample clinical research data, taking late onset AMI patients as the control, which should be paid early attention to and strictly managed.
- Conditions
- Lipid Disorder, Premature Myocardial Infarction
- Being tested
- No intervention
- Medical subject headings
- Lipid Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is a post-hoc analysis of a cross-sectional study.
| Study group | Role | What they receive |
|---|---|---|
| premature myocardial infarction | AMI with onset age less than 55 years for men and 65 years for women. Receives: Other: No intervention | |
| control | AMI with onset age not less than 55 years for men and 65 years for women. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The correlation between different blood lipid components and early onset AMI.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start1 Sep 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lipid DisorderStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Yue LI
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yue LI, First Affiliated Hospital of Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05645367
- Sponsor's protocol ID
- lipid and PMI
- Status last verified
- Dec 2022
- First submitted
- 2 Dec 2022
- Last updated
- 9 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associations of Lipid Measures With Premature Myocardial Infarction: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT05645367
- Acronym / sponsor ID
- lipid and PMI
- Conditions
- Lipid Disorder, Premature Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Yue LIUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 9 Dec 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.
Acute myocardial infarction (AMI) is the first cardiovascular cause of death that seriously threatens human health worldwide. Its incidence rate and mortality are increasing year by year and becoming younger. According to statistics, the average age of men and women with AMI for the first time is 65.6 years old and 72 years old respectively, of which 4%~10% AMI occurred before 45 years old. At present, there is no uniform age threshold for young AMI. Generally speaking, AMI with onset age less than 55 years for men and 65 years for women is called early-onset AMI, accounting for 5%~13% of AMI. Compared with elderly patients with AMI, patients with early onset AMI have different risk factors, clinical characteristics and prognosis, such as lower proportion of patients with diabetes and hypertension, more single vessel lesions and rare left main artery involvement, and higher long-term recurrence rate and mortality. Although the progress of preventive measures and treatment methods has reduced the hospitalization rate of elderly AMI patients, the number of young AMI patients in hospital is still rising. Therefore, in-depth analysis of the characteristics of risk factors of early onset AMI and early intervention are of great significance to reduce the risk of onset and improve long-term prognosis.
Hyperlipidemia is an independent risk factor for coronary heart disease at all ages, and is more closely related to early onset AMI. It is reported that more than 50% of early onset AMI patients are accompanied by hyperlipidemia. However, at present, the research on the relationship between blood lipids and early onset AMI is limited to the comparison of the level of single lipid component between early onset AMI and different control groups, or the comparative analysis of the relationship between a specific lipid component and the risk of early onset AMI with young healthy people. There is no research to compare the correlation between various lipid components and the risk of early onset AMI. Therefore, this study plans to deeply analyze the correlation between different blood lipid components and their ratios and early onset AMI, and further analyze which blood lipid indicators are most closely related to early onset AMI through large sample clinical research data, taking late onset AMI patients as the control, which should be paid early attention to and strictly managed.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| premature myocardial infarction | – | Other: No interventionAMI with onset age less than 55 years for men and 65 years for women. |
| control | – | Other: No interventionAMI with onset age not less than 55 years for men and 65 years for women. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- AMI patients who completed coronary angiography in the First Affiliated Hospital of Harbin Medical University from September 1, 2021 to September 31, 2022 were included consecutively to establish an AMI research queue. Baseline information such as demographic information, medical history information and laboratory examination results were collected through the electronic medical record system.
Key inclusion criteria (3 listed)
- According to the fourth Universal Definition of Myocardial Infarction (2018), the clinical diagnosis was acute myocardial infarction (AMI), including type 1, 2, 3, 4b and 4c.
- Complete coronary angiography
- Complete biochemical and blood lipid tests
Key exclusion criteria (4 listed)
- Recurrent AMI
- The onset of AMI exceeds 7 days
- Continuous taking of lipid-lowering drugs ≥ 5 days
- Patients with missing data
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 interventionThis is a post-hoc analysis of a cross-sectional study. | Other | control, premature myocardial infarction |
Primary outcome
The correlation between different blood lipid components and early onset AMI.
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
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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 Lipid Disorder and Premature Myocardial Infarction, run by Yue LI 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 4 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 9 Dec 2022. 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?
The correlation between different blood lipid components and early onset AMI. (time frame: 1 day). 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 Dec 2022.