Cardiovascular DiseasesCMCS-BeijingNCT04253054
Chinese Multi-provincial Cohort Study-Beijing Project
An observational study of Cardiovascular Diseases and Cardiovascular Risk Factor, run by Beijing Institute of Heart, Lung and Blood Vessel Diseases at 3 sites in China.
Trial summary
The Chinese Multi-provincial Cohort Study (CMCS)-Beijing project is a sub-study in CMCS participants from Beijing, which intended to investigate the progression and determinants of atherosclerosis and aging related health problems through repeat examinations. Exam 0 to Exam 3 have been conducted during 1992 to 2012. Read more about this study
- Who is it for?
- Ages 60 to 100 years
- Conditions the study is for
- Cardiovascular Diseases, Cardiovascular Risk Factor, Aging Problems
- What is being tested?
- Cardiovascular risk factors and Aging related health problems
- How many people
- 3,000 participants
- Where
- 3 sitesChina
- Study dates
- 7 Sep 2020to Mar 2021
- 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 60 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study participants were recruited from the Chinese Multi-provincial Cohort Study-Beijing Project
Who may be able to join
- Participants from CMCS-Beijing
- sign the informed consent
Who cannot join
- participanting in clinical trials
Trial locations and contacts
3 sites in 1 country.
China3 sites
Beijing Sijiqing Hospital, Beijing
Beijing
Peking University Hospital, Beijing
Beijing
Peking University Shougang Hospital
Beijing
About this study
The Chinese Multi-provincial Cohort Study (CMCS)-Beijing project is a sub-study in CMCS participants from Beijing, which intended to investigate the progression and determinants of atherosclerosis and aging related health problems through repeat examinations. Exam 0 to Exam 3 have been conducted during 1992 to 2012. Exam 4 is scheduled in 2020.
- Conditions
- Cardiovascular Diseases, Cardiovascular Risk Factor, Aging Problems, Smell Disorder, Sleep
- Being tested
- Cardiovascular risk factors, Aging related health problems
- Medical subject headings
- Cardiovascular Diseases, Olfaction Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular risk factorsOther
Different level of cardiovascular risk factors, such as aging, hypertension, diabetes, dyslipidemia, smoke, alcohol drink, obesity and et al, associated with genetics, environments and lifestyles
Aging related health problemsOther
Aging related health problems
What is being measured
The primary outcome is the main question the study is designed to answer.
All fatal and nonfatal acute coronary and stroke events
Acute coronary heart disease events included acute myocardial infarction, sudden death, and other coronary deaths. Acute stroke events included subarachnoid hemorrhage, intracerebral hemorrhage, or cerebral infarction.
Measured: From date of enrollment until the date of first documented event or date of cardiovascular death, whichever came first, assessed at least 5 years
Secondary outcomes (6)
New-onset of coronary events
Acute coronary heart disease events included acute myocardial infarction, sudden death, and other coronary deaths.
Measured: From date of enrollment until the date of first documented event or date of CHD death, whichever came first, assessed at least 5 years
New-onset of stroke
Acute stroke events included subarachnoid hemorrhage, intracerebral hemorrhage, or cerebral infarction.
Measured: From date of enrollment until the date of first documented event or date of stroke death, whichever came first, assessed at least 5 years
Total death
All cause death
Measured: From date of enrollment until date of death from all cause, assessed at least 5 years
Cognitive dysfunction
Cognitive dysfunction
Measured: From date of enrollment until date of first documented event, assessed at least 5 years
Olfactory Disorders
Olfactory Disorders
Measured: From date of enrollment until date of first documented event, assessed at least 5 years
Valvular disease
Valvular disease
Measured: From date of enrollment until the date of first documented event or date of valvular disease death, whichever came first, assessed at least 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start7 Sep 2020
- Primary completionMar 2021 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Institute of Heart, Lung and Blood Vessel Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jing Liu, MD, PhD, Principal investigator, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04253054
- Sponsor's protocol ID
- CMCS-Beijing 2020
- Acronym
- CMCS-Beijing
- Status last verified
- Dec 2020
- First submitted
- 22 Jan 2020
- Last updated
- 4 Dec 2020
- 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 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chinese Multi-provincial Cohort Study-Beijing Project
- ClinicalTrials.gov ID
- NCT04253054
- Acronym / sponsor ID
- CMCS-Beijing / CMCS-Beijing 2020
- Conditions
- Cardiovascular Diseases, Cardiovascular Risk Factor, Aging Problems, Smell Disorder, Sleep
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Beijing Institute of Heart, Lung and Blood Vessel DiseasesUniversity, hospital or other
- Study start
- 7 Sep 2020 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 5 Feb 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.
The Chinese Multi-provincial Cohort Study (CMCS)-Beijing project is a sub-study in CMCS participants from Beijing, which intended to investigate the progression and determinants of atherosclerosis and aging related health problems through repeat examinations. Exam 0 to Exam 3 have been conducted during 1992 to 2012. Exam 4 is scheduled in 2020.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants were recruited from the Chinese Multi-provincial Cohort Study-Beijing Project
Key inclusion criteria (2 listed)
- Participants from CMCS-Beijing
- sign the informed consent
Key exclusion criteria (1 listed)
- participanting in clinical trials
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 |
|---|---|---|
| Cardiovascular risk factorsDifferent level of cardiovascular risk factors, such as aging, hypertension, diabetes, dyslipidemia, smoke, alcohol drink, obesity and et al, associated with genetics, environments and lifestyles | Other | – |
| Aging related health problemsAging related health problems | Other | – |
Primary outcome
All fatal and nonfatal acute coronary and stroke events
Time frame: From date of enrollment until the date of first documented event or date of cardiovascular death, whichever came first, assessed at least 5 years
Acute coronary heart disease events included acute myocardial infarction, sudden death, and other coronary deaths. Acute stroke events included subarachnoid hemorrhage, intracerebral hemorrhage, or cerebral infarction.
6 secondary outcomes
New-onset of coronary events
Time frame: From date of enrollment until the date of first documented event or date of CHD death, whichever came first, assessed at least 5 years
New-onset of stroke
Time frame: From date of enrollment until the date of first documented event or date of stroke death, whichever came first, assessed at least 5 years
Total death
Time frame: From date of enrollment until date of death from all cause, assessed at least 5 years
Cognitive dysfunction
Time frame: From date of enrollment until date of first documented event, assessed at least 5 years
Olfactory Disorders
Time frame: From date of enrollment until date of first documented event, assessed at least 5 years
Valvular disease
Time frame: From date of enrollment until the date of first documented event or date of valvular disease death, whichever came first, assessed at least 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 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. This study is not recruiting at the moment.
Jing Liu, MD, PhD principal investigator
Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Diseases
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Cardiovascular Risk Factor, run by Beijing Institute of Heart, Lung and Blood Vessel Diseases at 3 sites 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 2 inclusion and 1 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 4 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
All fatal and nonfatal acute coronary and stroke events (time frame: From date of enrollment until the date of first documented event or date of cardiovascular death, whichever came first, assessed at least 5 years). 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 4 Dec 2020.