Coronary Artery DiseaseCRP-HanNCT00780221
C-Reactive Protein (CRP) Gene Variants and Coronary Artery Disease in a Chinese Han Population
An observational study of Coronary Artery Disease, run by Fudan University at 1 site in China.
Trial summary
The recognition of the association between circulating C-reactive protein (CRP) levels and risk of coronary heart disease (CHD) has led to an increased emphasis on CRP genetic effects on CRP level and CHD. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- Oct 2008to Dec 2010
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: in-hospital patients and community healthy individual
Who may be able to join
- clinical diagnosis of coronary artery disease
Who cannot join
- with major organ disfunction or acute inflammatory disease
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Chaoneng Wu, +86-21-64041990 ext. 2152, wuchaoneng@hotmail.com
Chaonneg Wu, PhD
About this study
Official title: CRP Gene Variants and Coronary Artery Disease in a Chinese Han Population
The recognition of the association between circulating C-reactive protein (CRP) levels and risk of coronary heart disease (CHD) has led to an increased emphasis on CRP genetic effects on CRP level and CHD. However, the causality of CRP variants remains uncertain.The objective of this study is to evaluate the association of CRP gene variants and CRP levels in CHD in Chinese Han population. We conduct case-control study in CRP-Han study participants. The common single-nucleotide polymorphisms (SNPs) in the CRP gene, haplotypes, and plasma CRP levels are detected. A Mendelian randomization analysis will be used to help test the likelihood of causal association of gene-CRP levels, CRP levels-CHD and gene-CHD. The investigators hypothesize that CRP gene variants influence the protein level and may participate in CHD progress.
Read the detailed description
CHD patients and non-CHD population are recruited. CRP level and CHD severity by coronary angiograph will be examined. Mendelian randomization analysis are taken to analyze statically.
- Conditions
- Coronary Artery Disease
- Keywords
- CRP, coronary artery disease, polymorphisms
- Medical subject headings
- Coronary Artery Disease
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 |
|---|---|---|
| control | patients without coronary artery disease | |
| case | patients with coronary artery disease |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionOct 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Investigators
- Junbo Ge, Study director, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00780221
- Sponsor's protocol ID
- ZSJQ-30725036
- Other IDs
- 30725036
- Acronym
- CRP-Han
- Status last verified
- Oct 2008
- First submitted
- 24 Oct 2008
- Last updated
- 27 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CRP Gene Variants and Coronary Artery Disease in a Chinese Han Population
- ClinicalTrials.gov ID
- NCT00780221
- Acronym / sponsor ID
- CRP-Han / ZSJQ-30725036
- Conditions
- Coronary Artery Disease
- Keywords
- CRP, coronary artery disease, polymorphisms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Oct 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 27 Oct 2008 (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.
The recognition of the association between circulating C-reactive protein (CRP) levels and risk of coronary heart disease (CHD) has led to an increased emphasis on CRP genetic effects on CRP level and CHD. However, the causality of CRP variants remains uncertain.The objective of this study is to evaluate the association of CRP gene variants and CRP levels in CHD in Chinese Han population. We conduct case-control study in CRP-Han study participants. The common single-nucleotide polymorphisms (SNPs) in the CRP gene, haplotypes, and plasma CRP levels are detected. A Mendelian randomization analysis will be used to help test the likelihood of causal association of gene-CRP levels, CRP levels-CHD and gene-CHD. The investigators hypothesize that CRP gene variants influence the protein level and may participate in CHD progress.
Detailed description
CHD patients and non-CHD population are recruited. CRP level and CHD severity by coronary angiograph will be examined. Mendelian randomization analysis are taken to analyze statically.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | – | –patients without coronary artery disease |
| case | – | –patients with coronary artery disease |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- in-hospital patients and community healthy individual
Key inclusion criteria (1 listed)
- clinical diagnosis of coronary artery disease
Key exclusion criteria (1 listed)
- with major organ disfunction or acute inflammatory disease
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2008.
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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.
Junbo Ge study director
Shanghai Zhongshan 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 Coronary Artery Disease, run by Fudan University 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 1 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 27 Oct 2008. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chaoneng Wu, PhD (+86-21-64041990 ext. 2152, wuchaoneng@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 27 Oct 2008.