Coronary Heart Disease and StrokeNCT02241239
A Comparison of the Estimates of Fuwai and Reynolds Risk Model
An observational study of Coronary Heart Disease and Stroke, run by Wuhan Asia Heart Hospital at 2 sites in China.
Trial summary
There are many risk prediction models. And their estimates are different. This study aimed to investigate the differences between the estimates of Fuwai and Reynolds risk model in Chinese, and investigate the reason for the differences. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Heart Disease and Stroke
- How many people
- 500 participants
- Where
- 2 sitesChina
- Study dates
- Aug 2014to Dec 2014
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: adults without coronary heart disease
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Wuhan Asia Heart Hospital
Wuhan, Hubei, 430000
Youping Chen, MD, +86-27-65796888, sageeeee@163.com
- Not yet recruiting
Wuhan Asia Heart Hospital
Wuhan, 430022
Youping Chen, M.D., +86-27-65796888 ext. 8501, sageeeee@163.com
Youping Chen, M.D,
About this study
There are many risk prediction models. And their estimates are different. This study aimed to investigate the differences between the estimates of Fuwai and Reynolds risk model in Chinese, and investigate the reason for the differences.
Read the detailed description
The participants will examined for cardiovascular risk factors, and their cardiovascular risks will be calculated based on the values of the risk factors using cardiovascular risk models. The estimates of different risk models will be compared, and the levels of traditional risk factors will be adjusted in order to evaluate the impacts of uncommon risk factors such as social and genetic risk factors.
- Conditions
- Coronary Heart Disease and Stroke
- Medical subject headings
- Coronary Disease, Stroke
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 |
|---|---|---|
| participants | healthy adults without stroke and coronary heart disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiovascular risk
The cardiovascular risk is the probability of the occurrence of coronary heart disease and stroke. The cardiovascular risk is calculated by risk prediction models based on the patient's risk factors.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart Disease and StrokeStudies 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuhan Asia Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Youping Chen, M.D., Principal investigator, Wuhan Asia Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02241239
- Sponsor's protocol ID
- 2014-0901-1
- Status last verified
- Aug 2014
- First submitted
- 31 Aug 2014
- Last updated
- 6 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Estimates of Fuwai and Reynolds Risk Model
- ClinicalTrials.gov ID
- NCT02241239
- Acronym / sponsor ID
- 2014-0901-1
- Conditions
- Coronary Heart Disease and Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Wuhan Asia Heart HospitalUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 16 Sep 2014 (estimated)
- 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.
There are many risk prediction models. And their estimates are different. This study aimed to investigate the differences between the estimates of Fuwai and Reynolds risk model in Chinese, and investigate the reason for the differences.
Detailed description
The participants will examined for cardiovascular risk factors, and their cardiovascular risks will be calculated based on the values of the risk factors using cardiovascular risk models. The estimates of different risk models will be compared, and the levels of traditional risk factors will be adjusted in order to evaluate the impacts of uncommon risk factors such as social and genetic risk factors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| participants | – | –healthy adults without stroke and coronary heart disease |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- adults without coronary heart disease
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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
cardiovascular risk
Time frame: 1 day
The cardiovascular risk is the probability of the occurrence of coronary heart disease and stroke. The cardiovascular risk is calculated by risk prediction models based on the patient's risk factors.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2014.
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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.
Youping Chen, M.D. principal investigator
Wuhan Asia Heart Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Heart Disease and Stroke, run by Wuhan Asia Heart Hospital at 2 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 0 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 6 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Contact Youping Chen, M.D, (+86-27-65796888 ext. 8501, sageeeee@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiovascular risk (time frame: 1 day). 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 6 Nov 2014.