Coronary Artery DiseaseNCT00260104
Risk Factors of Individuals With Coronary Artery Disease
An observational study of Coronary Artery Disease, run by Nanjing Medical University at 1 site in China.
Trial summary
It would be useful to study coronary arteriovenous difference of various markers in patients who are undergoing coronary angiography for suspected coronary artery disease. Environmental and genetic factors may play a role in the progression of coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- How many people
- Not given
- Where
- 1 siteChina
- Study dates
- Nov 2005to not given
- 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 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- This is a study only of Chinese.
- Subjects will be allowed to participate if they self-identify as Chinese.
- The age range of the participants will be between 18 and 89 years.
- The study group will consist of consecutive patients who are undergoing coronary angiography for suspected coronary artery disease.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
It would be useful to study coronary arteriovenous difference of various markers in patients who are undergoing coronary angiography for suspected coronary artery disease. Environmental and genetic factors may play a role in the progression of coronary artery disease. The goal of this project is to establish a series of cross-sectional / case-control studies to evaluate risk factors of coronary artery disease in China.
Read the detailed description
This study is designed to investigate the epidemiologic, genetic, laboratory and clinical characterization of individuals with coronary artery disease. The study group will consist of consecutive patients who are undergoing coronary angiography for suspected coronary artery disease. The diagnosis of coronary artery disease will be confirmed by coronary angiography performed with the Judkins technique using a quantitative coronary angiographic system. Coronary artery disease will be considered to be present if there is a diameter stenosis of at least 50% in at least one of the three major epicardial coronary arteries. The number of diseased vessels will be determined and a classification of 1-, 2-, and 3-vessel disease will be used. Coronary artery segments will be defined according to the Coronary Artery Surgery Study classification. Blood samples from vein and coronary artery will be collected. We will study coronary arteriovenous difference of various markers. Urinary samples will be obtained the day of coronary angiography. We will explore the environmental (including family history, life style, diet, physical activity, neuropsychological functioning，plasma levels of oxidative stress factors, angiogenic factors, and inflammatory markers, etc.) and genetic (including oxidative stress factors and inflammatory factors, etc.) risk factors. We will study the association between various environmental risk factors with the clinical characterization and correlation between the genetic polymorphisms and the presence of coronary artery disease.
- Conditions
- Coronary Artery Disease
- Medical subject headings
- 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 posted1 Dec 2005 (estimated)
- Study startNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Nanjing Medical 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
- Time perspective
- Retrospective
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Investigators
- Bin Wang, Ph.D, Principal investigator, Department of Pharmacology, Institute of Clinical Pharmacology, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00260104
- Sponsor's protocol ID
- ICP058
- Status last verified
- May 2008
- First submitted
- 29 Nov 2005
- Last updated
- 26 May 2008
- Results posted
- No
Publications
Tang NP, Wang LS, Yang L, Gu HJ, Zhu HJ, Zhou B, Sun QM, Cong RH, Wang B. Preproghrelin Leu72Met polymorphism in Chinese subjects with coronary artery disease and controls. Clin Chim Acta. 2008 Jan;387(1-2):42-7. doi: 10.1016/j.cca.2007.08.014. Epub 2007 Sep 5.
PubMed 17884032
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors of Individuals With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT00260104
- Acronym / sponsor ID
- ICP058
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Nov 2005
- First posted
- 1 Dec 2005 (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.
It would be useful to study coronary arteriovenous difference of various markers in patients who are undergoing coronary angiography for suspected coronary artery disease. Environmental and genetic factors may play a role in the progression of coronary artery disease. The goal of this project is to establish a series of cross-sectional / case-control studies to evaluate risk factors of coronary artery disease in China.
Detailed description
This study is designed to investigate the epidemiologic, genetic, laboratory and clinical characterization of individuals with coronary artery disease. The study group will consist of consecutive patients who are undergoing coronary angiography for suspected coronary artery disease. The diagnosis of coronary artery disease will be confirmed by coronary angiography performed with the Judkins technique using a quantitative coronary angiographic system. Coronary artery disease will be considered to be present if there is a diameter stenosis of at least 50% in at least one of the three major epicardial coronary arteries. The number of diseased vessels will be determined and a classification of 1-, 2-, and 3-vessel disease will be used. Coronary artery segments will be defined according to the Coronary Artery Surgery Study classification. Blood samples from vein and coronary artery will be collected. We will study coronary arteriovenous difference of various markers. Urinary samples will be obtained the day of coronary angiography. We will explore the environmental (including family history, life style, diet, physical activity, neuropsychological functioning，plasma levels of oxidative stress factors, angiogenic factors, and inflammatory markers, etc.) and genetic (including oxidative stress factors and inflammatory factors, etc.) risk factors. We will study the association between various environmental risk factors with the clinical characterization and correlation between the genetic polymorphisms and the presence of coronary artery disease.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- This is a study only of Chinese.
- Subjects will be allowed to participate if they self-identify as Chinese.
- The age range of the participants will be between 18 and 89 years.
- The study group will consist of consecutive patients who are undergoing coronary angiography for suspected coronary artery disease.
Key exclusion criteria (0 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
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 26 May 2008.
- Results publication: PubMed 17884032Tang NP, Wang LS, Yang L, Gu HJ, Zhu HJ, Zhou B, Sun QM, Cong RH, Wang B. Preproghrelin Leu72Met polymorphism in Chinese subjects with coronary artery disease and controls. Clin Chim Acta. 2008 Jan;387(1-2):42-7. doi: 10.1016/j.cca.2007.08.014. Epub 2007 Sep 5.
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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.
Bin Wang, Ph.D principal investigator
Department of Pharmacology, Institute of Clinical Pharmacology, Nanjing Medical University
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 Nanjing Medical 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 4 inclusion and 0 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 26 May 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 Bin Wang, Ph.D (0086-25-86862884, binwang@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00260104, which also lists 1 linked publication.
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 26 May 2008.