AtherosclerosisIMTNCT00784264
A Study on Intima Media Thickness (IMT) in Middle-aged Subjects
An observational study of Atherosclerosis, run by AstraZeneca at 1 site in Hong Kong.
Trial summary
This is an observational study to measure the thickness of artery walls in the neck (intima media thickness IMT) by ultrasound examination in middle-aged subjects with central obesity. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Atherosclerosis
- How many people
- 200 participants
- Where
- 1 siteHong Kong
- Study dates
- Oct 2008to Jun 2009
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: aged 55 or above with central obesity, male more than 90 cm; female more than 80 cm
Who may be able to join
- Male or female aged 55 years or above.
- Waist circumference: male more than 90 cm; female more than 80 cm.
Who cannot join
- Any known chronic diseases requiring long-term medication such as hypertension, diabetes and hyperlipidemia.
- Presence of known cardiovascular diseases including cerebro-vascular disease, coronary heart disease and peripheral artery disease.
- Presence of any active major diseases that may interfere the physical conditions and body weight of subjects during the study period, which include malignancy, infection, renal or liver function impairment, recent major surgery (within 3 months).
Trial locations and contacts
1 site in 1 country.
About this study
This is an observational study to measure the thickness of artery walls in the neck (intima media thickness IMT) by ultrasound examination in middle-aged subjects with central obesity. The purpose of this study is to obtain local data how common asymptomatic atherosclerosis is, and to investigate the association between Cardiovascular Disease risk factors and intima media thickness (IMT) in the Hong Kong population. Results from this study may enhance the public awareness of asymptomatic atherosclerosis and understand its role in the development of Cardiovascular Disease in Hong Kong.
- Conditions
- Atherosclerosis
- Keywords
- Asymptomatic atherosclerosis, Intima media thickness (IMT), central obesity, cardiovascular disease
- Medical subject headings
- Atherosclerosis, Obesity, Abdominal, Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the prevalence of asymptomatic atherosclerosis by measurement of intima media thickness (IMT) in middle-aged subjects with central obesity in Hong Kong,
Measured: during the one single study visit
Secondary outcomes (2)
To examine the association between IMT value and cardiovascular disease (CVD) risk factors, and blood lipid and glucose profiles in middle-aged centrally obese subjects in Hong Kong.
Measured: During the one single study visit
IMT results to be compared with what being reported in the recent literature on normal Chinese population.
Measured: During the one single study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2008 (estimated)
- Study startOct 2008
- Study completionJun 2009
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.
- More trials run by AstraZenecaThe 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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Karen Yuen, Study director, AstraZeneca Hong Kong LtdChun chung Chow, MD, Principal investigator, Prince of Wales Hospital, Shatin, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00784264
- Sponsor's protocol ID
- NIS-CHK-DUM-2008/1
- Acronym
- IMT
- Status last verified
- Jan 2010
- First submitted
- 22 Oct 2008
- Last updated
- 12 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Intima Media Thickness (IMT) in Middle-aged Subjects
- ClinicalTrials.gov ID
- NCT00784264
- Acronym / sponsor ID
- IMT / NIS-CHK-DUM-2008/1
- Conditions
- Atherosclerosis
- Keywords
- Asymptomatic atherosclerosis, Intima media thickness (IMT), central obesity, cardiovascular disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Study completion
- Jun 2009 (actual)
- First posted
- 3 Nov 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.
This is an observational study to measure the thickness of artery walls in the neck (intima media thickness IMT) by ultrasound examination in middle-aged subjects with central obesity. The purpose of this study is to obtain local data how common asymptomatic atherosclerosis is, and to investigate the association between Cardiovascular Disease risk factors and intima media thickness (IMT) in the Hong Kong population. Results from this study may enhance the public awareness of asymptomatic atherosclerosis and understand its role in the development of Cardiovascular Disease in Hong Kong.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- aged 55 or above with central obesity, male more than 90 cm; female more than 80 cm
Key inclusion criteria (2 listed)
- Male or female aged 55 years or above.
- Waist circumference: male more than 90 cm; female more than 80 cm.
Key exclusion criteria (3 listed)
- Any known chronic diseases requiring long-term medication such as hypertension, diabetes and hyperlipidemia.
- Presence of known cardiovascular diseases including cerebro-vascular disease, coronary heart disease and peripheral artery disease.
- Presence of any active major diseases that may interfere the physical conditions and body weight of subjects during the study period, which include malignancy, infection, renal or liver function impairment, recent major surgery (within 3 months).
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
To investigate the prevalence of asymptomatic atherosclerosis by measurement of intima media thickness (IMT) in middle-aged subjects with central obesity in Hong Kong,
Time frame: during the one single study visit
2 secondary outcomes
To examine the association between IMT value and cardiovascular disease (CVD) risk factors, and blood lipid and glucose profiles in middle-aged centrally obese subjects in Hong Kong.
Time frame: During the one single study visit
IMT results to be compared with what being reported in the recent literature on normal Chinese population.
Time frame: During the one single study visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 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.
Karen Yuen study director
AstraZeneca Hong Kong Ltd
Chun chung Chow, MD principal investigator
Prince of Wales Hospital, Shatin, Hong Kong
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, run by AstraZeneca at 1 site in Hong Kong.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 12 Jan 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 Hong Kong. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate the prevalence of asymptomatic atherosclerosis by measurement of intima media thickness (IMT) in middle-aged subjects with central obesity in Hong Kong, (time frame: during the one single study visit). 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 12 Jan 2010.