LipidNCT04212520
Predictive Value of Non-fasting Blood Lipid Levels for Cardiovascular Events in Community Population(PICC Study)
An observational study of Lipid, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
Numerous studies have shown that non-fasting blood lipid levels are closely related to the occurrence of cardiovascular and cerebrovascular events, but it is still unclear in the Chinese population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lipid
- How many people
- 6,500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 31 Dec 2050
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: Study population includes subjects who living in community, of any race or ethnicity, 18 or older years of age, and have provided written informed consent.
Who may be able to join
- •≥18 years old;
- Signed informed consent;
- Life expectancy is greater than 1 year.
Who cannot join
- mental disorder;
- is not willing to participate in the clinical study;
- suffered with other disease to quite the trial;
- violated the protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Feng Ying-qing, PhD, +862083827812, 651792209@qq.com
About this study
Official title: Predictive Value of Non-fasting Blood Lipid Levels for Cardiovascular and Cerebrovascular Events in Community Population(PICC Study)
Numerous studies have shown that non-fasting blood lipid levels are closely related to the occurrence of cardiovascular and cerebrovascular events, but it is still unclear in the Chinese population. The purpose of the study is to investigate the association between non-fasting blood lipid levels and adverse outcomes in Chinese community population.
Read the detailed description
Study population includes subjects who living in community, of any race or ethnicity, 18 or older years of age, and have provided written informed consent to provide biological sample at one or more study visits. Physical examination, questionnaire survey and biological sample collection will be conducted at baseline and the incidence of a composite of major adverse cardiovascular events will be investigated during follow-up.
- Conditions
- Lipid
- Being tested
- No intervention
- Keywords
- non-fasting lipid, cardiovascular and cerebrovascular events, major adverse cardiovascular events
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
All-cause mortality was confirmed through a combination of hospital medical records, telephone contacts with patients or family members, and death registration at the Center for Disease Control and Prevention.
Measured: Through study completion, an average of 1 years
Cardiovascular Mortality
Cardiovascular mortality was defined as death attributable to an ischemic cardiovascular cause (including fatal cardiovascular events and stroke).
Measured: Through study completion, an average of 1 years
Cardiovascular and cerebrovascular diseases
The number of and the incidence rate of cardiovascular and cerebrovascular diseases.
Measured: Through study completion, an average of 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2019
- Study start1 Jan 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LipidStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's 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
- 6,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Feng Ying-qing, PhD, Study chair, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04212520
- Sponsor's protocol ID
- 2018150H(R2)
- Status last verified
- Dec 2019
- First submitted
- 24 Dec 2019
- Last updated
- 13 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Non-fasting Blood Lipid Levels for Cardiovascular and Cerebrovascular Events in Community Population(PICC Study)
- ClinicalTrials.gov ID
- NCT04212520
- Acronym / sponsor ID
- 2018150H(R2)
- Conditions
- Lipid
- Keywords
- non-fasting lipid, cardiovascular and cerebrovascular events, major adverse cardiovascular events
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6,500 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2050 (estimated)
- First posted
- 27 Dec 2019 (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.
Numerous studies have shown that non-fasting blood lipid levels are closely related to the occurrence of cardiovascular and cerebrovascular events, but it is still unclear in the Chinese population. The purpose of the study is to investigate the association between non-fasting blood lipid levels and adverse outcomes in Chinese community population.
Detailed description
Study population includes subjects who living in community, of any race or ethnicity, 18 or older years of age, and have provided written informed consent to provide biological sample at one or more study visits. Physical examination, questionnaire survey and biological sample collection will be conducted at baseline and the incidence of a composite of major adverse cardiovascular events will be investigated during follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Study population includes subjects who living in community, of any race or ethnicity, 18 or older years of age, and have provided written informed consent.
Key inclusion criteria (3 listed)
- •≥18 years old;
- Signed informed consent;
- Life expectancy is greater than 1 year.
Key exclusion criteria (4 listed)
- mental disorder;
- is not willing to participate in the clinical study;
- suffered with other disease to quite the trial;
- violated the protocol.
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 interventionNo intervention | Other | – |
Primary outcome
All-cause mortality
Time frame: Through study completion, an average of 1 years
All-cause mortality was confirmed through a combination of hospital medical records, telephone contacts with patients or family members, and death registration at the Center for Disease Control and Prevention.
Cardiovascular Mortality
Time frame: Through study completion, an average of 1 years
Cardiovascular mortality was defined as death attributable to an ischemic cardiovascular cause (including fatal cardiovascular events and stroke).
Cardiovascular and cerebrovascular diseases
Time frame: Through study completion, an average of 1 years
The number of and the incidence rate of cardiovascular and cerebrovascular diseases.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
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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.
Feng Ying-qing, PhD study chair
Guangdong Provincial People's 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 Lipid, run by Guangdong Provincial People's Hospital 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: looking for participants now, as of the sponsor's last update on 13 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Feng Ying-qing, PhD (+862083827812, 651792209@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: Through study completion, an average of 1 years). The study lists 3 primary outcomes in all. 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 13 Jan 2020.