Lipoprotein DisorderNCT05081440
A Multi-center, Prospective, Observational Study to Describe the siTuation of Blood Lipid mAnagement Among the Population With hypeRtension and/or Type 2 diabeTes in Community Health Center
An observational study of Lipoprotein Disorder, run by Huashan Hospital.
Trial summary
A multi-center, prospective, observational Study to describe the siTuation of blood lipid mAnagement among the population with hypeRtension and/or type 2 diabeTes in Community Health Center Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lipoprotein Disorder
- How many people
- 5,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2021to 1 Dec 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 5000 patients with hypeRtension and/or type 2 diabeTes inCommunity Health Center
Who may be able to join
- The informed consent form (ICF) should be signed before conducting any research-related operations
- Age ≥18 years
- Patients with well-diagnosed hypertension (HTN) and/or type 2 diabetes (T2DM) and have been ill for ≥ 3 months
- The patient underwent fasting lipid analysis in the past 1 month and the data was fully recorded
Who cannot join
- 1.Patients with well-diagnosed atherosclerotic cardiovascular disease (ASCVD) 2. Have received any form of lipid-lowering treatment within 4 weeks before the screening period 3. The patient is currently participating in any other clinical trial except this study
- -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multi-center, Prospective, Observational Study to Describe the siTuation of Blood Lipid mAnagement Among the Population With hypeRtension and/or Type 2 diabeTes in Community Health Center(START-CHC)
A multi-center, prospective, observational Study to describe the siTuation of blood lipid mAnagement among the population with hypeRtension and/or type 2 diabeTes in Community Health Center
- Conditions
- Lipoprotein Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients diagnosed with hypertension or diabetes | Age ≥18 years; Patients with well-diagnosed hypertension (HTN) and/or type 2 diabetes (T2DM) and have been ill for ≥ 3 months; The patient underwent fasting lipid analysis in the past 1 month and the data was fully recorded |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary outcome
To evaluate the blood lipid levels and current status of drug treatment in patients with CHC hypertension and/or type 2 diabetes Describe the characteristics of blood lipid treatment in patients with CHC with hypertension and/or type 2 diabetes with LDL-C between 2.6 and 4.1 mmol/L
Measured: 2022.12.01
Secondary outcomes (1)
secondary outcome
To evaluate the ASCVD risk stratification and the level of blood lipids in patients with CHC hypertension and/or type 2 diabetes.
Evaluate the blood lipid level of patients with hypertension and/or type 2 diabetes in CHC with LDL-C between 2.6 and 4.1mmol/L (LDL-C/Non-HDL) To explore the compliance of patients with CHC hypertension and/or type 2 diabetes with LDL-C between 2.6 and 4.1 mmol/L for lipid-lowering therapy.
Measured: 2022.12.01
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start1 Dec 2021 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lipoprotein 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
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Yong Li, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05081440
- Sponsor's protocol ID
- START-CHC
- Status last verified
- Oct 2021
- First submitted
- 5 Oct 2021
- Last updated
- 18 Oct 2021
- 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 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Prospective, Observational Study to Describe the siTuation of Blood Lipid mAnagement Among the Population With hypeRtension and/or Type 2 diabeTes in Community Health Center(START-CHC)
- ClinicalTrials.gov ID
- NCT05081440
- Acronym / sponsor ID
- START-CHC
- Conditions
- Lipoprotein Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 18 Oct 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.
A multi-center, prospective, observational Study to describe the siTuation of blood lipid mAnagement among the population with hypeRtension and/or type 2 diabeTes in Community Health Center
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients diagnosed with hypertension or diabetes | – | –Age ≥18 years; Patients with well-diagnosed hypertension (HTN) and/or type 2 diabetes (T2DM) and have been ill for ≥ 3 months; The patient underwent fasting lipid analysis in the past 1 month and the data was fully recorded |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 5000 patients with hypeRtension and/or type 2 diabeTes inCommunity Health Center
Key inclusion criteria (4 listed)
- The informed consent form (ICF) should be signed before conducting any research-related operations
- Age ≥18 years
- Patients with well-diagnosed hypertension (HTN) and/or type 2 diabetes (T2DM) and have been ill for ≥ 3 months
- The patient underwent fasting lipid analysis in the past 1 month and the data was fully recorded
Key exclusion criteria (2 listed)
- 1.Patients with well-diagnosed atherosclerotic cardiovascular disease (ASCVD) 2. Have received any form of lipid-lowering treatment within 4 weeks before the screening period 3. The patient is currently participating in any other clinical trial except this study
- -
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
primary outcome
Time frame: 2022.12.01
To evaluate the blood lipid levels and current status of drug treatment in patients with CHC hypertension and/or type 2 diabetes Describe the characteristics of blood lipid treatment in patients with CHC with hypertension and/or type 2 diabetes with LDL-C between 2.6 and 4.1 mmol/L
1 secondary outcome
secondary outcome
Time frame: 2022.12.01
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2021.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Lipoprotein Disorder, run by Huashan 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 4 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: status not confirmed, as of the sponsor's last update on 18 Oct 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 yong li (+86 13801753494, liyong606@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
primary outcome (time frame: 2022.12.01). 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 18 Oct 2021.