AtherosclerosisNCT01208116
A Prospective Study on Predictive Value of Non-Invasive Atherosclerotic Measurements in Elderly Chinese
An observational study of Atherosclerosis and Cardiovascular Disease, run by Tianjin Medical University General Hospital at 1 site in China.
Trial summary
The purpose of this study is to determine whether non-invasive atherosclerotic measurements (baPWV, IMT, FMD, CACS, ABI) are valuable predictors for cardiovascular events in elderly. At inception, routine physical examination and non-invasive atherosclerotic measurements will conducted on all participants. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis, Cardiovascular Disease
- What is being tested?
- Cardiovascular events
- How many people
- 1,290 participants
- Where
- 1 siteChina
- Study dates
- Apr 2010to 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects with an age>=60 years, who are designated for healthcare in Tianjin Medical University General Hospital will be enrolled in the study and there is no restriction on gender. Medical histroy are recorded precisely. The protocol was approved by our Institutional Ethics Committee and all subjects give informed consent before participating.
Who may be able to join
- Chinese, age>=60, no gender restriction.
- To be able to apply the measurement mentioned above.
- Medical history are maintained precisely.
- Tianjin Medical University General Hospital is the participants' designated hospital by national health authority.
Who cannot join
- Systemic inflammation.
- Malignant tumor
- Chronic lung disease
- Liver disease
- Aortic aneurysm
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Geriatric Department, Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
Ning Sun, M.D., +86 13820220028, ss9981@sina.com
About this study
The purpose of this study is to determine whether non-invasive atherosclerotic measurements (baPWV, IMT, FMD, CACS, ABI) are valuable predictors for cardiovascular events in elderly. At inception, routine physical examination and non-invasive atherosclerotic measurements will conducted on all participants. Then they will be followed prospectively for at least 2 years. All cardiovascular and other health events will be recorded.
Read the detailed description
Cardiovascular disease is the most common cause of morbidity and mortality in the world, especially in elderly. Conventional risk factors are widely used in clinical practice, but it is inadequate and inaccurate due to no direct evaluation of artery. However, invasive method, it is difficult to be applied in atherosclerosis screening and only used in advanced institutions, is expensive and unacceptable. We are trying to assess the value of noninvasive measurements in predicting cardiovascular events.
Five invasive methods will be applied in the study, including
- brachial-ankle Pulse Wave Velocity(baPWV)
- Carotid Intimal-Medial Thickness(CIMT)
- Flow Mediated Dilation(FMD)
- Ankle-Brachial Index(ABI)
- Coronary Artery Calcification Score(CACS)
These indices represent not only different phase of atherosclerosis, but also various sections and arterial layers.
- Conditions
- Atherosclerosis, Cardiovascular Disease
- Being tested
- Cardiovascular events
- Keywords
- Atherosclerosis, Prognosis, Flow-mediated dilatation, Brachial-ankle pulse wave velocity, Carotid Intimal-Medial Thickness, coronary artery calcification score, Ankle-brachial index
- Medical subject headings
- Atherosclerosis, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular eventsOther
- Coronary intervention
- Infarction
- Congestive heart failure
- Stroke
- Cardiac death
| Study group | Role | What they receive |
|---|---|---|
| Subgroups | According to the demographic features, subjects may be divided into some subgroups. Receives: Other: Cardiovascular events |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2010 (estimated)
- Study startApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies 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
- 1,290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ning Sun, M.D., Study director, Tianjin Medical University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01208116
- Sponsor's protocol ID
- B2009A055
- Status last verified
- Sep 2010
- First submitted
- 22 Sep 2010
- Last updated
- 23 Sep 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on Predictive Value of Non-Invasive Atherosclerotic Measurements in Elderly Chinese
- ClinicalTrials.gov ID
- NCT01208116
- Acronym / sponsor ID
- B2009A055
- Conditions
- Atherosclerosis, Cardiovascular Disease
- Keywords
- Atherosclerosis, Prognosis, Flow-mediated dilatation, Brachial-ankle pulse wave velocity, Carotid Intimal-Medial Thickness, coronary artery calcification score, Ankle-brachial index
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,290 participants (estimated)
- Lead sponsor
- Tianjin Medical University General HospitalUniversity, hospital or other
- Study start
- Apr 2010
- First posted
- 23 Sep 2010 (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 purpose of this study is to determine whether non-invasive atherosclerotic measurements (baPWV, IMT, FMD, CACS, ABI) are valuable predictors for cardiovascular events in elderly. At inception, routine physical examination and non-invasive atherosclerotic measurements will conducted on all participants. Then they will be followed prospectively for at least 2 years. All cardiovascular and other health events will be recorded.
Detailed description
Cardiovascular disease is the most common cause of morbidity and mortality in the world, especially in elderly. Conventional risk factors are widely used in clinical practice, but it is inadequate and inaccurate due to no direct evaluation of artery. However, invasive method, it is difficult to be applied in atherosclerosis screening and only used in advanced institutions, is expensive and unacceptable. We are trying to assess the value of noninvasive measurements in predicting cardiovascular events.
Five invasive methods will be applied in the study, including
- brachial-ankle Pulse Wave Velocity(baPWV)
- Carotid Intimal-Medial Thickness(CIMT)
- Flow Mediated Dilation(FMD)
- Ankle-Brachial Index(ABI)
- Coronary Artery Calcification Score(CACS)
These indices represent not only different phase of atherosclerosis, but also various sections and arterial layers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subgroups | – | Other: Cardiovascular eventsAccording to the demographic features, subjects may be divided into some subgroups. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with an age>=60 years, who are designated for healthcare in Tianjin Medical University General Hospital will be enrolled in the study and there is no restriction on gender. Medical histroy are recorded precisely. The protocol was approved by our Institutional Ethics Committee and all subjects give informed consent before participating.
Key inclusion criteria (4 listed)
- Chinese, age>=60, no gender restriction.
- To be able to apply the measurement mentioned above.
- Medical history are maintained precisely.
- Tianjin Medical University General Hospital is the participants' designated hospital by national health authority.
Key exclusion criteria (5 listed)
- Systemic inflammation.
- Malignant tumor
- Chronic lung disease
- Liver disease
- Aortic aneurysm
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 events* Coronary intervention * Infarction * Congestive heart failure * Stroke * Cardiac death | Other | Subgroups |
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 23 Sep 2010.
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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.
Ning Sun, M.D. study director
Tianjin Medical University General 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 Atherosclerosis and Cardiovascular Disease, run by Tianjin Medical University General Hospital 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 5 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 23 Sep 2010. 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 Ning Sun, M.D. (+86 13820220028, ss9981@sina.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 23 Sep 2010.