Familial HypercholesterolemiaNCT04958629
A Prospective Cohort Study on Familial Hypercholesterolemia in Health Examination Population
An observational study of Familial Hypercholesterolemia, run by Peking University Third Hospital.
Trial summary
To determine the prevalence and the prognosis in a corhort of patients with familial hypercholesterolemia (FH). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Familial Hypercholesterolemia
- What is being tested?
- familial hypercholesterolemia
- How many people
- 318 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2021to 31 Dec 2023
- How long will I take part?
- 2 Years
- 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 hyperlipidemia were screened from health examination population. Among the selected patients with hyperlipidemia, those who met the following inclusion and exclusion criteria were included in the study cohort as FH group or non-FH group.
Who may be able to join
- 1) Patients with definite diagnosis of hyperlipidemia.
Who cannot join
- Age < 18.
- Do not agree to participate in this study.
- secondary hypercholesterolemia.
- Phytosteronemia.
Trial locations and contacts
No sites are listed yet.
About this study
To determine the prevalence and the prognosis in a corhort of patients with familial hypercholesterolemia (FH).
Read the detailed description
This study aims to achieve the following goals through prospective cohort study and statistical analysis: (1) to determine the prevalence of familial hypercholesterolemia (FH) in healthy people with hypercholesterolemia.（2) Compared with non FH population, the relative risk of atherosclerotic cardiovascular disease (ASCVD) in FH patients in China was calculated, and the risk prediction model of ASCVD in FH patients was constructed by using biochemical results, imaging data, biomarkers and other indicators.（3) To evaluate the benefits of different lipid-lowering strategies for FH patients in China.（4) To analyze the gene carriers of FH patients in China.
- Conditions
- Familial Hypercholesterolemia
- Being tested
- familial hypercholesterolemia
- Keywords
- familial hypercholesterolemia, prognosis
- Medical subject headings
- Hyperlipoproteinemia Type II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
familial hypercholesterolemiaOther
Among the selected patients with hyperlipidemia, those who met the diagnostic criteria of FH were included in the study cohort as FH group.
| Study group | Role | What they receive |
|---|---|---|
| non-FH Group | Not described | |
| FH Group | Not described Receives: Other: familial hypercholesterolemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with atherosclerotic cardiovascular disease (ASCVD) events
- Fatal or non-fatal myocardial infarction; 2) Fatal or non-fatal ischemic stroke; 3) Coronary artery revascularization; 4) Peripheral artery revascularization; 5) Cardiogenic death
Measured: 2 years from enrollmet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start1 Oct 2021 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Familial HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by Peking University Third 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
- Prospective
- Enrolment
- 318 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei Gao, Doctor, Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04958629
- Sponsor's protocol ID
- M2021098
- Status last verified
- Jun 2021
- First submitted
- 27 Jun 2021
- Last updated
- 20 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study on Familial Hypercholesterolemia in Health Examination Population
- ClinicalTrials.gov ID
- NCT04958629
- Acronym / sponsor ID
- M2021098
- Conditions
- Familial Hypercholesterolemia
- Keywords
- familial hypercholesterolemia, prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 318 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Oct 2021 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 12 Jul 2021 (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 determine the prevalence and the prognosis in a corhort of patients with familial hypercholesterolemia (FH).
Detailed description
This study aims to achieve the following goals through prospective cohort study and statistical analysis: (1) to determine the prevalence of familial hypercholesterolemia (FH) in healthy people with hypercholesterolemia.（2) Compared with non FH population, the relative risk of atherosclerotic cardiovascular disease (ASCVD) in FH patients in China was calculated, and the risk prediction model of ASCVD in FH patients was constructed by using biochemical results, imaging data, biomarkers and other indicators.（3) To evaluate the benefits of different lipid-lowering strategies for FH patients in China.（4) To analyze the gene carriers of FH patients in China.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-FH Group | – | – |
| FH Group | – | Other: familial hypercholesterolemia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hyperlipidemia were screened from health examination population. Among the selected patients with hyperlipidemia, those who met the following inclusion and exclusion criteria were included in the study cohort as FH group or non-FH group.
Key inclusion criteria (1 listed)
- 1) Patients with definite diagnosis of hyperlipidemia.
Key exclusion criteria (4 listed)
- Age < 18.
- Do not agree to participate in this study.
- secondary hypercholesterolemia.
- Phytosteronemia.
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 |
|---|---|---|
| familial hypercholesterolemiaAmong the selected patients with hyperlipidemia, those who met the diagnostic criteria of FH were included in the study cohort as FH group. | Other | FH Group |
Primary outcome
Number of participants with atherosclerotic cardiovascular disease (ASCVD) events
Time frame: 2 years from enrollmet
1) Fatal or non-fatal myocardial infarction; 2) Fatal or non-fatal ischemic stroke; 3) Coronary artery revascularization; 4) Peripheral artery revascularization; 5) Cardiogenic death
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2021.
- 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.
Wei Gao, Doctor study chair
Peking University Third Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Familial Hypercholesterolemia, run by Peking University Third 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 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 20 Sep 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Gao, Doctor (+86 13901366179, weigao@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with atherosclerotic cardiovascular disease (ASCVD) events (time frame: 2 years from enrollmet). 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 20 Sep 2021.