Coronary AtherosclerosisNCT00431977
Validation Study of Coronary CT Angiography as a Screening Tool in Asymptomatic Diabetes
A study testing coronary computed tomography angiography in people with Coronary Atherosclerosis and Diabetes Mellitus, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the prevalence and clinical predictors of subclinical coronary atherosclerosis and to validate the usefulness of coronary CT angiography as a screening tool in asymptomatic patients with type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Coronary Atherosclerosis, Diabetes Mellitus
- What is being tested?
- coronary computed tomography angiography
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2006to Dec 2012
- Phase
- Interventional
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus
- Age 50 ~ 75 years
Who cannot join
- angina pectoris or anginal equivalent symptoms
- insulin pump user or history of ketoacidosis
- history of myocardial infarction, heart failure, or coronary revascularization
- electrocardiographic evidence of Q-wave myocardial infarction, ischemic ST- segment or T-wave changes, or complete left bundle branch block
- uncontrolled arrythmia
- hypersensitivity to contrast dye
Show all 10Show fewer
- renal failure
- uncontrolled arrythmia
- hypersensitivity to contrast dye
- renal failure
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang hospital
Sungnam-si, Gyeonggi-do
About this study
Official title: DEtection of Subclinical Coronary AtheRosclerosis in diabeTES Using Coronary CT Angiography (DESCARTES Trial)
The purpose of this study is to evaluate the prevalence and clinical predictors of subclinical coronary atherosclerosis and to validate the usefulness of coronary CT angiography as a screening tool in asymptomatic patients with type 2 diabetes mellitus.
Read the detailed description
Coronary artery disease (CAD) is the leading cause of death in patients with diabetes. Patients with diabetes are known to have silent myocardial ischemia more frequently than those without diabetes. Furthermore, CAD in patients with diabetes frequently manifested in advance stage, and morbidity and mortality are higher than those without diabetes. Early screening and treatment of CAD in asymptomatic patients with diabetes might reduce high morbidity and mortality.
In recent advance in technology, coronary CT angiography makes it more accurately and easier in detecting CAD not only in symptomatic patients but also in asymptomatic population. In asymptomatic population, coronary CT angiography could detect subclinical coronary atherosclerosis with high sensitivity and specificity. However, there is a paucity of information on the role of coronary CT angiography as a screening method in high risk asymptomatic population, i.e. asymptomatic patients with diabetes.
Therefore in our study, we will evaluate the prevalence and clinical predictors of subclinical coronary atherosclerosis and to validate the usefulness of coronary CT angiography as a screening tool in asymptomatic patients with type 2 diabetes mellitus.
In this study, we will recruit asymptomatic patients with diabetes. At the time of enrollment, patients will be randomly assigned to coronary CT angiography group or control group using web-based randomization table. One-half of patients will be assigned to coronary CT angiography imaging and follow-up, whereas the other half will be randomized to medical treatment and follow-up only.
When the patients are eligible for study, investigators will give information about the study and obtain written consent. The presence of chest pain symptom will be screened with Rose questionnaire. Medical history and physical examination will be performed, and baseline laboratory work-up will be performed. Investigators will evaluate the status of diabetic complication (retinopathy/nephropathy/cardiac autonomic neuropathy).
After initial clinical and laboratory evaluation, all patients will be followed for adverse cardiac events for 5 years.
- Conditions
- Coronary Atherosclerosis, Diabetes Mellitus
- Being tested
- coronary computed tomography angiography
- Keywords
- Coronary Atherosclerosis, Diabetes Mellitus
- Medical subject headings
- Coronary Artery Disease, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coronary computed tomography angiographyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial infarction
Late revascularization therapy
Cardiac death
Secondary outcomes (3)
Early revascularization therapy
Other procedure (i.e. peripheral vascular procedure)
All-caused death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2007 (estimated)
- Study startNov 2006
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Huk-Jae Chang, MD, PhD, Study director, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00431977
- Sponsor's protocol ID
- B-0610/038-002
- Status last verified
- Oct 2006
- First submitted
- 5 Feb 2007
- Last updated
- 21 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DEtection of Subclinical Coronary AtheRosclerosis in diabeTES Using Coronary CT Angiography (DESCARTES Trial)
- ClinicalTrials.gov ID
- NCT00431977
- Acronym / sponsor ID
- B-0610/038-002
- Conditions
- Coronary Atherosclerosis, Diabetes Mellitus
- Keywords
- Coronary Atherosclerosis, Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Nov 2006
- Study completion
- Dec 2012
- First posted
- 6 Feb 2007 (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 evaluate the prevalence and clinical predictors of subclinical coronary atherosclerosis and to validate the usefulness of coronary CT angiography as a screening tool in asymptomatic patients with type 2 diabetes mellitus.
Detailed description
Coronary artery disease (CAD) is the leading cause of death in patients with diabetes. Patients with diabetes are known to have silent myocardial ischemia more frequently than those without diabetes. Furthermore, CAD in patients with diabetes frequently manifested in advance stage, and morbidity and mortality are higher than those without diabetes. Early screening and treatment of CAD in asymptomatic patients with diabetes might reduce high morbidity and mortality.
In recent advance in technology, coronary CT angiography makes it more accurately and easier in detecting CAD not only in symptomatic patients but also in asymptomatic population. In asymptomatic population, coronary CT angiography could detect subclinical coronary atherosclerosis with high sensitivity and specificity. However, there is a paucity of information on the role of coronary CT angiography as a screening method in high risk asymptomatic population, i.e. asymptomatic patients with diabetes.
Therefore in our study, we will evaluate the prevalence and clinical predictors of subclinical coronary atherosclerosis and to validate the usefulness of coronary CT angiography as a screening tool in asymptomatic patients with type 2 diabetes mellitus.
In this study, we will recruit asymptomatic patients with diabetes. At the time of enrollment, patients will be randomly assigned to coronary CT angiography group or control group using web-based randomization table. One-half of patients will be assigned to coronary CT angiography imaging and follow-up, whereas the other half will be randomized to medical treatment and follow-up only.
When the patients are eligible for study, investigators will give information about the study and obtain written consent. The presence of chest pain symptom will be screened with Rose questionnaire. Medical history and physical examination will be performed, and baseline laboratory work-up will be performed. Investigators will evaluate the status of diabetic complication (retinopathy/nephropathy/cardiac autonomic neuropathy).
After initial clinical and laboratory evaluation, all patients will be followed for adverse cardiac events for 5 years.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type 2 diabetes mellitus
- Age 50 ~ 75 years
Key exclusion criteria (10 listed)
- angina pectoris or anginal equivalent symptoms
- insulin pump user or history of ketoacidosis
- history of myocardial infarction, heart failure, or coronary revascularization
- electrocardiographic evidence of Q-wave myocardial infarction, ischemic ST- segment or T-wave changes, or complete left bundle branch block
- uncontrolled arrythmia
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 |
|---|---|---|
| coronary computed tomography angiography | Procedure or surgery | – |
Primary outcome
Myocardial infarction
Late revascularization therapy
Cardiac death
3 secondary outcomes
Early revascularization therapy
Other procedure (i.e. peripheral vascular procedure)
All-caused death
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 21 Jun 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.
Huk-Jae Chang, MD, PhD study director
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing coronary computed tomography angiography in people with Coronary Atherosclerosis and Diabetes Mellitus, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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 10 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 21 Jun 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 South Korea. 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?
Myocardial infarction. The study lists 3 primary outcomes in all. 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 Jun 2011.