ThromboembolismNCT01319201
Subclinical Atherosclerosis Using Dual-source CT Coronary Angiography in Chinese Adults With Different Glycaemic Status
An observational study of Thromboembolism, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
Part I: Survey of Coronary Artery Calcification and Stenosis in Participants with Different Glycaemic Status Aims: To evaluate coronary artery calcification and stenosis in community-dwelling adults with different glycaemic status, using dual-source CT angiography (CTA) Study Subjects and Methods: 200 adults with… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Thromboembolism
- Type of treatment
- Pill or oral medicine
- How many people
- 600 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 200 adults with normal glucose regulation (NGR), 200 with impaired glucose regulation (IGR) and 200 with type 2 diabetes were recruited from an urban community of Shanghai
Who may be able to join
- Age between 40 and 70 years old
- Gender: males and females
- Provide written informed consent
- Satisfactory compliance
Who cannot join
- History of cardiovascular diseases
- Allergy to iodine
- Exposure to radiation within last 3 months
- ALT more than 100IU/L, or serum creatine more than 133μmol/l [1.5mg/dl] or GFR less than 60ml/min
- Heart rate more than 100 bpm or severe arrhythmia
- Malignancy, myocardial infection, acute hepatitis or other major diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Subclinical Atherosclerosis Using Dual-source Computed Tomography Coronary Angiography in Chinese Adults With Different Glycaemic Status
Part I: Survey of Coronary Artery Calcification and Stenosis in Participants with Different Glycaemic Status
Aims:
Read more
To evaluate coronary artery calcification and stenosis in community-dwelling adults with different glycaemic status, using dual-source CT angiography (CTA)
Study Subjects and Methods:
200 adults with normal glucose regulation (NGR), 200 with impaired glucose regulation (IGR) and 200 with type 2 diabetes were recruited from an urban community of Shanghai, who then underwent a comprehensive examination including questionnaire, anthropometric measurements, biochemical analysis and CTA.
Part II: Follow-up of Cardiovascular Events and Re-evaluation of Coronary Artery Calcification and Stenosis
Aims and Methods:
To investigate the development of cardiovascular diseases in subjects recruited in part I and re-evaluate coronary artery calcification and stenosis using CTA after 3-year follow-up
To identify the predictive value of coronary artery calcification and stenosis with future risks of cardiovascular diseases and the possible development of coronary artery disorders among participants with different glycaemic status
- Conditions
- Thromboembolism
- Medical subject headings
- Thromboembolism
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 |
|---|---|---|
| Impaired glucose regulation | This group of subjects was diagnosed as impaired glucose regulation using oral glucose tolerance test. | |
| Type 2 diabetes | This group of subjects was diagnosed as type 2 diabetes using oral glucose tolerance test. | |
| Normal glucose regulation | This group of subjects was considered normal regarding glucose metabolism using oral glucose tolerance test. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who will develop cardiovascular events during follow-up
Cardiovascular events include non-fatal myocardial infarction, non-fatal stroke and cardiovascular death. The progression of coronary artery calcium and stenosis is also evaluated at the final visit.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2011 (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 ThromboembolismStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Investigators
- Guang Ning, M.D.; PH.D., Principal investigator, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01319201
- Sponsor's protocol ID
- CCEMD009
- Status last verified
- Mar 2011
- First submitted
- 18 Mar 2011
- Last updated
- 21 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Subclinical Atherosclerosis Using Dual-source Computed Tomography Coronary Angiography in Chinese Adults With Different Glycaemic Status
- ClinicalTrials.gov ID
- NCT01319201
- Acronym / sponsor ID
- CCEMD009
- Conditions
- Thromboembolism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Apr 2010
- First posted
- 21 Mar 2011 (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.
Part I: Survey of Coronary Artery Calcification and Stenosis in Participants with Different Glycaemic Status
Aims:
To evaluate coronary artery calcification and stenosis in community-dwelling adults with different glycaemic status, using dual-source CT angiography (CTA)
Study Subjects and Methods:
200 adults with normal glucose regulation (NGR), 200 with impaired glucose regulation (IGR) and 200 with type 2 diabetes were recruited from an urban community of Shanghai, who then underwent a comprehensive examination including questionnaire, anthropometric measurements, biochemical analysis and CTA.
Part II: Follow-up of Cardiovascular Events and Re-evaluation of Coronary Artery Calcification and Stenosis
Aims and Methods:
To investigate the development of cardiovascular diseases in subjects recruited in part I and re-evaluate coronary artery calcification and stenosis using CTA after 3-year follow-up
To identify the predictive value of coronary artery calcification and stenosis with future risks of cardiovascular diseases and the possible development of coronary artery disorders among participants with different glycaemic status
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Impaired glucose regulation | – | –This group of subjects was diagnosed as impaired glucose regulation using oral glucose tolerance test. |
| Type 2 diabetes | – | –This group of subjects was diagnosed as type 2 diabetes using oral glucose tolerance test. |
| Normal glucose regulation | – | –This group of subjects was considered normal regarding glucose metabolism using oral glucose tolerance test. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 200 adults with normal glucose regulation (NGR), 200 with impaired glucose regulation (IGR) and 200 with type 2 diabetes were recruited from an urban community of Shanghai
Key inclusion criteria (4 listed)
- Age between 40 and 70 years old
- Gender: males and females
- Provide written informed consent
- Satisfactory compliance
Key exclusion criteria (6 listed)
- History of cardiovascular diseases
- Allergy to iodine
- Exposure to radiation within last 3 months
- ALT more than 100IU/L, or serum creatine more than 133μmol/l [1.5mg/dl] or GFR less than 60ml/min
- Heart rate more than 100 bpm or severe arrhythmia
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
Number of participants who will develop cardiovascular events during follow-up
Time frame: 3 years
Cardiovascular events include non-fatal myocardial infarction, non-fatal stroke and cardiovascular death. The progression of coronary artery calcium and stenosis is also evaluated at the final visit.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2011.
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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.
Guang Ning, M.D.; PH.D. principal investigator
Shanghai Jiao Tong University School of Medicine
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 Thromboembolism, run by Shanghai Jiao Tong University School of Medicine 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 6 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 21 Mar 2011. 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?
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?
Number of participants who will develop cardiovascular events during follow-up (time frame: 3 years). 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 21 Mar 2011.