DyslipidemiasNCT04220164
Observation of Blood Lipid Outcomes in Lipid Clinic
An observational study of Dyslipidemias, run by Mackay Memorial Hospital at 1 site in Taiwan.
Trial summary
Taipei MacKay Memorial Hospital will establish a Lipid Clinic for hyperlipidemic patients. In this Lipid Clinic, the physician will discuss with each individual patient and set an individualized LDL goal according to current guideline and regulation of National Health Insurance Administration (NHIA). Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemias
- What is being tested?
- Education and inform the optimal threshold of LDL-C levels
- How many people
- 500 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Jan 2020to 31 Dec 2025
- How long will I take part?
- 5 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who are ≥20 years, have abnormal lipid profiles, need lipid-lowering drugs according to 2017 Taiwan Lipid Guideline in Lipid Clinic of Taipei MacKay Memorial Hospital.
Who may be able to join
- ≥20 years-old
- Abnormal lipid profiles according to 2017 Taiwan Lipid Guideline for High-risk Patients
Who cannot join
- Reject to participate in this study
- Pregnant women
- Prisoner
- Illiteracy
- HIV patients
- Individuals who are mentally retarded, homeless, and handicapped
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taiwan, Taipei, Mackay Memorial hospital
Taipei, 104
Ting-Yun Lu, 886-2-25433535 ext. 3256, tingyunlu@gmail.com
About this study
Official title: Observation of Blood Lipid Outcomes in Patients Who Receive Treatment in Lipid Clinic of Taipei MacKay Memorial Hospital
Taipei MacKay Memorial Hospital will establish a Lipid Clinic for hyperlipidemic patients. In this Lipid Clinic, the physician will discuss with each individual patient and set an individualized LDL goal according to current guideline and regulation of National Health Insurance Administration (NHIA). The aim of this study is to observe blood lipid outcomes in patients who receive treatment in Lipid Clinic of Taipei MacKay Memorial Hospital.
Read the detailed description
Hyperlipidemia is a major risk factor of atherosclerotic cardiovascular disease (ASCVD), and therefore it is beneficial to prevent the risk of ASCVD by controlling the prevalence of hyperlipidemia. According to CEPHEUS Pan-Asia survey, the rate of LDL goal attainment in hyperlipidemic patients of Taiwan was suboptimal, especially in high-risk patients. 2017 Taiwan lipid guideline for high-risk patients has been published and clearly defined the treatment goal of blood LDL-C for high-risk patients. Besides, Taipei MacKay Memorial Hospital will establish a Lipid Clinic for hyperlipidemic patients. In this Lipid Clinic, the physician will discuss with each individual patient and set an individualized LDL goal according to current guideline and regulation of National Health Insurance Administration (NHIA). The aim of this study is to observe blood lipid outcomes in patients who receive treatment in Lipid Clinic of Taipei MacKay Memorial Hospital.
- Conditions
- Dyslipidemias
- Being tested
- Education and inform the optimal threshold of LDL-C levels
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education and inform the optimal threshold of LDL-C levelsOther
Physicians educate patients and provide a clear information about optimal LDL-C value according to individual patient's condition according to current guidelines
| Study group | Role | What they receive |
|---|---|---|
| Dyslipidemic patients | Patients who meet the criteria of high-risk category according to 2017 Taiwan Lipid Guideline for High-Risk Patients have a abnormal serum LDL-C level Receives: Other: Education and inform the optimal threshold of LDL-C levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid profile
check serum level of LDL-C
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start3 Jan 2020 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2025 (estimated)
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 DyslipidemiasStudies 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
- Other
- Enrolment
- 500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Sponsor
- Investigators
- Chao-Feng Lin, PhD, Principal investigator, Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04220164
- Sponsor's protocol ID
- 18MMHIS083e
- Status last verified
- Jan 2020
- First submitted
- 26 Dec 2019
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not provide IPD to other researchers according to IRB regulation.
Publications
Li YH, Ueng KC, Jeng JS, Charng MJ, Lin TH, Chien KL, Wang CY, Chao TH, Liu PY, Su CH, Chien SC, Liou CW, Tang SC, Lee CC, Yu TY, Chen JW, Wu CC, Yeh HI; Writing Group of 2017 Taiwan Lipid Guidelines for High Risk Patients. 2017 Taiwan lipid guidelines for high risk patients. J Formos Med Assoc. 2017 Apr;116(4):217-248. doi: 10.1016/j.jfma.2016.11.013. Epub 2017 Feb 24.
PubMed 28242176
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation of Blood Lipid Outcomes in Patients Who Receive Treatment in Lipid Clinic of Taipei MacKay Memorial Hospital
- ClinicalTrials.gov ID
- NCT04220164
- Acronym / sponsor ID
- 18MMHIS083e
- Conditions
- Dyslipidemias
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- 3 Jan 2020 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 Jan 2020 (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.
Taipei MacKay Memorial Hospital will establish a Lipid Clinic for hyperlipidemic patients. In this Lipid Clinic, the physician will discuss with each individual patient and set an individualized LDL goal according to current guideline and regulation of National Health Insurance Administration (NHIA). The aim of this study is to observe blood lipid outcomes in patients who receive treatment in Lipid Clinic of Taipei MacKay Memorial Hospital.
Detailed description
Hyperlipidemia is a major risk factor of atherosclerotic cardiovascular disease (ASCVD), and therefore it is beneficial to prevent the risk of ASCVD by controlling the prevalence of hyperlipidemia. According to CEPHEUS Pan-Asia survey, the rate of LDL goal attainment in hyperlipidemic patients of Taiwan was suboptimal, especially in high-risk patients. 2017 Taiwan lipid guideline for high-risk patients has been published and clearly defined the treatment goal of blood LDL-C for high-risk patients. Besides, Taipei MacKay Memorial Hospital will establish a Lipid Clinic for hyperlipidemic patients. In this Lipid Clinic, the physician will discuss with each individual patient and set an individualized LDL goal according to current guideline and regulation of National Health Insurance Administration (NHIA). The aim of this study is to observe blood lipid outcomes in patients who receive treatment in Lipid Clinic of Taipei MacKay Memorial Hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dyslipidemic patients | – | Other: Education and inform the optimal threshold of LDL-C levelsPatients who meet the criteria of high-risk category according to 2017 Taiwan Lipid Guideline for High-Risk Patients have a abnormal serum LDL-C level |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are ≥20 years, have abnormal lipid profiles, need lipid-lowering drugs according to 2017 Taiwan Lipid Guideline in Lipid Clinic of Taipei MacKay Memorial Hospital.
Key inclusion criteria (2 listed)
- ≥20 years-old
- Abnormal lipid profiles according to 2017 Taiwan Lipid Guideline for High-risk Patients
Key exclusion criteria (6 listed)
- Reject to participate in this study
- Pregnant women
- Prisoner
- Illiteracy
- HIV patients
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 |
|---|---|---|
| Education and inform the optimal threshold of LDL-C levelsPhysicians educate patients and provide a clear information about optimal LDL-C value according to individual patient's condition according to current guidelines | Other | Dyslipidemic patients |
Primary outcome
Lipid profile
Time frame: 12 month
check serum level of LDL-C
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
- Background: PubMed 28242176Li YH, Ueng KC, Jeng JS, Charng MJ, Lin TH, Chien KL, Wang CY, Chao TH, Liu PY, Su CH, Chien SC, Liou CW, Tang SC, Lee CC, Yu TY, Chen JW, Wu CC, Yeh HI; Writing Group of 2017 Taiwan Lipid Guidelines for High Risk Patients. 2017 Taiwan lipid guidelines for high risk patients. J Formos Med Assoc. 2017 Apr;116(4):217-248. doi: 10.1016/j.jfma.2016.11.013. Epub 2017 Feb 24.
- Individual participant dataSharing planned: No. We will not provide IPD to other researchers according to IRB regulation.
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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.
Chao-Feng Lin, PhD principal investigator
Mackay Memorial Hospital
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 Dyslipidemias, run by Mackay Memorial Hospital at 1 site in Taiwan.
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 2 inclusion and 6 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 7 Jan 2020. 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 Taiwan. 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?
Contact Ting-Yun Lu (886-2-25433535 ext. 3256, tingyunlu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lipid profile (time frame: 12 month). 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 NCT04220164, 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 7 Jan 2020.