Vascular DiseaseNCT00820378
The Epidemiology of Aortic Diameter in China
An observational study of Vascular Disease and Diabetes, run by Zhejiang University at 2 sites in China.
Trial summary
Aortic aneurysms are the major disease processes affecting the aorta and becoming a relatively common cause of death because of rupture or dissection. The most common location for aneurysms is the infrarenal abdominal aorta, followed by the ascending thoracic aorta. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Vascular Disease, Diabetes, Hypertension
- What is being tested?
- No special interventioin
- How many people
- 2,000 participants
- Where
- 2 sitesChina
- Study dates
- Jan 2009to Dec 2015
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chinese population with clinically evident arterial disease or cardiovascular risk factors
Who may be able to join
- Patients aged 40 to 100 were referred to the hospital with a recent diagnosis of clinically evident arterial disease or a cardiovascular risk factor.
Who cannot join
- Those with connective tissue disease, congenital heart disease, cardiomyopathy, congestive heart failure,rheumatic arthritis, secondary causes of hypertension, or active cancer.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Second Affiliated Hospital of Zhejiang University College of Medicine
Hangzhou, Zhejiang, 317000
Zhao-xia Pu, 86-13989488402, zhaoxiapu@163.com
Zhao-xia Pu, MD
- Recruiting
Taizhou Hospital, Wenzhou Medical College
Taizhou, Zhejiang, 317000
Li-jiang Tang, 86-13606655138, taizhoutang@hotmail.com
Li-jiang Tang
About this study
Official title: Epidemiology of Aortic Dimensions in Patients With Clinically Evident Arterial Disease or Cardiovascular Risk Factors
Aortic aneurysms are the major disease processes affecting the aorta and becoming a relatively common cause of death because of rupture or dissection. The most common location for aneurysms is the infrarenal abdominal aorta, followed by the ascending thoracic aorta. Unlike coronary heart disease, the incidence of abdominal aortic aneurysm (AAA) in the United States and Europe has been increasing, and this increase may not be due to higher levels of screening for this condition alone. Aortic diameter is central to the diagnosis of aortic aneurysm. Furthermore, it was demonstrated that non-AAA patients with an enlarged diameter of the infrarenal aortic diameter are also at high risk for all-cause mortality. And aortic root dimension was associated with several coronary artery disease (CHD) risk factors and measures of subclinical disease and was predictive of incident congestive heart failure (CHF), stroke, cardiovascular disease (CVD) mortality, and all-cause mortality, but not of incident MI. Up to now, there are limited studies on the epidemiology of aortic diameter, especially in Chinese population.
Read the detailed description
The purpose of this study was to analyze the size of the entire aorta at different anatomic levels in a large group of Chinese population with clinically evident arterial disease or cardiovascular risk factors to further explored the risk factors and potential alternative pathomechanisms for the development of aortic dilatation. Comprehensive transthoracic M-mode, 2-dimensional, and Doppler echocardiographic studies will be performed using commercially available equipment. The aortic dimensions were assessed at end-diastole at the different levels: (1) the annulus, (2) the mid-point of the sinuses of Valsalva, (3) the sinotubular junction, (4) the ascending aorta at the level of its largest diameter, (5) the transverse arch, (6) the descending aorta posterior to the left atrium, and (7) the abdominal aorta just distal to the origin of the renal arteries. The extension of dilation is defined as the number of dilated aortic segments. The relations among aortic dimensions and clinical characteristics will be assessed by multiple regression analysis. The current study was to determine the association of risk factors of CVD and atherosclerosis diseases with aortic dimension in Chinese patients with clinical event atherosclerotic disease or risk factors of atherosclerotic disease.
- Conditions
- Vascular Disease, Diabetes, Hypertension, Hyperlipidemia
- Being tested
- No special interventioin
- Keywords
- Aortic dimension, Atherosclerosis, Vascular disease, Risk factors
- Medical subject headings
- Vascular Diseases, Diabetes Mellitus, Hypertension, Hyperlipidemias, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No special interventioinOther
Comprehensive transthoracic M-mode, 2-dimensional, and Doppler echocardiographic studies will be performed using commercially available equipment. The aortic dimensions were assessed at end-diastole at the different levels:
| Study group | Role | What they receive |
|---|---|---|
| atherosclerosis | Patients With Clinically Evident Arterial Disease or Cardiovascular Risk Factors Receives: Other: No special interventioin |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2010 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular DiseaseStudies of the same condition, open and under way.
- More trials run by Zhejiang 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 crossover
- Time perspective
- Cross-sectional
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Taizhou Hospital
- Investigators
- Jian-an Wang, Study chair, Second Affiliated Hospital, Zhejiang University, School of MedicineLi-jiang Tang, Principal investigator, Taizhou Hospital, Wenzhou Medical CollegeXiao-feng Chen, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of MedicineZhao-xia Pu, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of MedicineXian-fang Lin, Principal investigator, Taizhou Hospital, Wenzhou Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00820378
- Sponsor's protocol ID
- EPAD
- Status last verified
- Jan 2009
- First submitted
- 8 Jan 2009
- Last updated
- 14 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Aortic Dimensions in Patients With Clinically Evident Arterial Disease or Cardiovascular Risk Factors
- ClinicalTrials.gov ID
- NCT00820378
- Acronym / sponsor ID
- EPAD
- Conditions
- Vascular Disease, Diabetes, Hypertension, Hyperlipidemia
- Keywords
- Aortic dimension, Atherosclerosis, Vascular disease, Risk factors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Taizhou Hospital
- Study start
- Jan 2009
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 12 Jan 2009 (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.
Aortic aneurysms are the major disease processes affecting the aorta and becoming a relatively common cause of death because of rupture or dissection. The most common location for aneurysms is the infrarenal abdominal aorta, followed by the ascending thoracic aorta. Unlike coronary heart disease, the incidence of abdominal aortic aneurysm (AAA) in the United States and Europe has been increasing, and this increase may not be due to higher levels of screening for this condition alone. Aortic diameter is central to the diagnosis of aortic aneurysm. Furthermore, it was demonstrated that non-AAA patients with an enlarged diameter of the infrarenal aortic diameter are also at high risk for all-cause mortality. And aortic root dimension was associated with several coronary artery disease (CHD) risk factors and measures of subclinical disease and was predictive of incident congestive heart failure (CHF), stroke, cardiovascular disease (CVD) mortality, and all-cause mortality, but not of incident MI. Up to now, there are limited studies on the epidemiology of aortic diameter, especially in Chinese population.
Detailed description
The purpose of this study was to analyze the size of the entire aorta at different anatomic levels in a large group of Chinese population with clinically evident arterial disease or cardiovascular risk factors to further explored the risk factors and potential alternative pathomechanisms for the development of aortic dilatation. Comprehensive transthoracic M-mode, 2-dimensional, and Doppler echocardiographic studies will be performed using commercially available equipment. The aortic dimensions were assessed at end-diastole at the different levels: (1) the annulus, (2) the mid-point of the sinuses of Valsalva, (3) the sinotubular junction, (4) the ascending aorta at the level of its largest diameter, (5) the transverse arch, (6) the descending aorta posterior to the left atrium, and (7) the abdominal aorta just distal to the origin of the renal arteries. The extension of dilation is defined as the number of dilated aortic segments. The relations among aortic dimensions and clinical characteristics will be assessed by multiple regression analysis. The current study was to determine the association of risk factors of CVD and atherosclerosis diseases with aortic dimension in Chinese patients with clinical event atherosclerotic disease or risk factors of atherosclerotic disease.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| atherosclerosis | – | Other: No special interventioinPatients With Clinically Evident Arterial Disease or Cardiovascular Risk Factors |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese population with clinically evident arterial disease or cardiovascular risk factors
Key inclusion criteria (1 listed)
- Patients aged 40 to 100 were referred to the hospital with a recent diagnosis of clinically evident arterial disease or a cardiovascular risk factor.
Key exclusion criteria (1 listed)
- Those with connective tissue disease, congenital heart disease, cardiomyopathy, congestive heart failure,rheumatic arthritis, secondary causes of hypertension, or active cancer.
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 special interventioinComprehensive transthoracic M-mode, 2-dimensional, and Doppler echocardiographic studies will be performed using commercially available equipment. The aortic dimensions were assessed at end-diastole at the different levels: | Other | atherosclerosis |
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 14 Jan 2009.
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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.
Jian-an Wang study chair
Second Affiliated Hospital, Zhejiang University, School of Medicine
Li-jiang Tang principal investigator
Taizhou Hospital, Wenzhou Medical College
Xiao-feng Chen principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
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 Vascular Disease and Diabetes, run by Zhejiang University 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 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 14 Jan 2009. 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 Xiao-feng Chen, MD. (86-13656680890, zjxiaofengchen@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 14 Jan 2009.