Diabetes MellitusNCT00321542
Coronary CT Angiography in Asymptomatic Diabetes Mellitus
An observational study of Diabetes Mellitus, run by Carmel Medical Center at 1 site in Israel.
Trial summary
The study aims to examine if non-invasive imaging of the coronary arteries by CT angiography using an intra-venous injection of X-ray contrast medium in asymptomatic patients with adult onset diabetes mellitus can predict the risk of developing coronary heart disease. Read more about this study
- Who is it for?
- Ages 55 to 74 years
- Conditions the study is for
- Diabetes Mellitus
- How many people
- 793 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2006to Sep 2017
- 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 55 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Type 2 diabtes mellitus, age 55-74 yrs, no known coronary artery disease
Who may be able to join
- Type II diabetes mellitus
- No symptoms of coronary heart disease
- At least one additional risk factor for coronary artery disease
Who cannot join
- Known coronary artery disease
- Kidney failure if more than mild
- Allergy to iodinated X-ray contrast media
- Chronic atrial fibrillation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Additive Value of Multislice Computed Tomographic Angiography of the Coronary Arteries in the Prediction of Acute Cardiac Events in Asymptomatic Individuals With Type II Diabetes Mellitus
The study aims to examine if non-invasive imaging of the coronary arteries by CT angiography using an intra-venous injection of X-ray contrast medium in asymptomatic patients with adult onset diabetes mellitus can predict the risk of developing coronary heart disease.
Read the detailed description
Patients having diabetes mellitus are at increased risk for the development of coronary heart disease. Available tests do not accurately predict which diabetic patients are at greatest risk of suffering from a coronary event. The recent development of coronary CT angiography allows non-invasive imaging of both coronary narrowing and of disease (atheroma) in the coronary arterial wall at an earlier stage of the disease before the development of coronary arterial narrowing.
In this study we will collect all the readily available patient medical data relating to diabetes and its complications and other coronary artery disease risk factors. In addition patients will be referred for exercise stress testing and for eye examinations. The coronary CT angiogram will be carefully examined for early signs of coronary artery disease. In the event of a finding on the CT scan requiring medical therapy this will be communicated to the patient and his treating physician. In the event of a finding on the stress test or CT scan requiring further medical work-up the patient will be referred to the cardiology clinic.
In general patients will be followed in the regular diabetic clinic and by their family practitioners.
In the event of any acute symptoms over the next few years possibly related to heart disease and requiring emergency room examination patients will be requested to report to the emergency room at the hospital at which the CT study was performed whenever possible.In such an event a repeat CT scan will be performed to examine if any new findings are present. In the event of any new complaints requiring referral to an out of hospital clinic patients will be referred for further assessment to the cardiology clinic and a repeat CT scan may be performed if deemed relevant.
Outcomes of all patients will be examined at 2 years or later using computerized databases. Patients undergoing hospitalization during the follow up period of at least 2-3 years will be contacted by the study staff to obtain further details of the event and hospital findings .
An analysis wil be performed of the value of CT angiography in relation to the traditional risk factors and other available medical data in the prediction of later coronary heart disease and other vascular events.
- Conditions
- Diabetes Mellitus
- Being tested
- Imaging study, No intervention
- Keywords
- Computed tomography, Diabetes mellitus, Coronary atherosclerosis, Non-invasive imaging
- Medical subject headings
- Diabetes Mellitus, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imaging study, No interventionOther
Also called Philips Brilliance 64 computed tomography scanner
Imaging with coronary computed tomographic angiography
What is being measured
The primary outcome is the main question the study is designed to answer.
Death or acute myocardial infarction
Measured: 7 years
Secondary outcomes (1)
Composite of the primary outcome and the onset of new symptoms of coronary artery disease with proven myocardial ischemia (supported by treadmill, nuclear scan or stress echo findings) or the need for a revascularization procedure.
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2006 (estimated)
- Study startSep 2006
- Primary completionSep 2015 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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
- 793 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- European Foundation for the Study of Diabetes
- Responsible party
- Sponsor
- Investigators
- David A Halon, MB ChB, FACC, Study director, Lady Davis Carmel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00321542
- Sponsor's protocol ID
- CT-DM
- Status last verified
- Feb 2015
- First submitted
- 2 May 2006
- Last updated
- 29 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Scognamiglio R, Negut C, Ramondo A, Tiengo A, Avogaro A. Detection of coronary artery disease in asymptomatic patients with type 2 diabetes mellitus. J Am Coll Cardiol. 2006 Jan 3;47(1):65-71. doi: 10.1016/j.jacc.2005.10.008. Epub 2005 Dec 9.
PubMed 16386666Leber AW, Knez A, von Ziegler F, Becker A, Nikolaou K, Paul S, Wintersperger B, Reiser M, Becker CR, Steinbeck G, Boekstegers P. Quantification of obstructive and nonobstructive coronary lesions by 64-slice computed tomography: a comparative study with quantitative coronary angiography and intravascular ultrasound. J Am Coll Cardiol. 2005 Jul 5;46(1):147-54. doi: 10.1016/j.jacc.2005.03.071.
PubMed 15992649Halon DA, Dobrecky-Mery I, Gaspar T, Azencot M, Yaniv N, Peled N, Lewis BS. Pulse pressure and coronary atherosclerosis in asymptomatic type 2 diabetes mellitus: a 64 channel cardiac computed tomography analysis. Int J Cardiol. 2010 Aug 6;143(1):63-71. doi: 10.1016/j.ijcard.2009.01.066. Epub 2009 Feb 25.
PubMed 19246107
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Additive Value of Multislice Computed Tomographic Angiography of the Coronary Arteries in the Prediction of Acute Cardiac Events in Asymptomatic Individuals With Type II Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00321542
- Acronym / sponsor ID
- CT-DM
- Conditions
- Diabetes Mellitus
- Keywords
- Computed tomography, Diabetes mellitus, Coronary atherosclerosis, Non-invasive imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 793 participants (actual)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Collaborators
- European Foundation for the Study of Diabetes
- Study start
- Sep 2006
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 3 May 2006 (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 study aims to examine if non-invasive imaging of the coronary arteries by CT angiography using an intra-venous injection of X-ray contrast medium in asymptomatic patients with adult onset diabetes mellitus can predict the risk of developing coronary heart disease.
Detailed description
Patients having diabetes mellitus are at increased risk for the development of coronary heart disease. Available tests do not accurately predict which diabetic patients are at greatest risk of suffering from a coronary event. The recent development of coronary CT angiography allows non-invasive imaging of both coronary narrowing and of disease (atheroma) in the coronary arterial wall at an earlier stage of the disease before the development of coronary arterial narrowing.
In this study we will collect all the readily available patient medical data relating to diabetes and its complications and other coronary artery disease risk factors. In addition patients will be referred for exercise stress testing and for eye examinations. The coronary CT angiogram will be carefully examined for early signs of coronary artery disease. In the event of a finding on the CT scan requiring medical therapy this will be communicated to the patient and his treating physician. In the event of a finding on the stress test or CT scan requiring further medical work-up the patient will be referred to the cardiology clinic.
In general patients will be followed in the regular diabetic clinic and by their family practitioners.
In the event of any acute symptoms over the next few years possibly related to heart disease and requiring emergency room examination patients will be requested to report to the emergency room at the hospital at which the CT study was performed whenever possible.In such an event a repeat CT scan will be performed to examine if any new findings are present. In the event of any new complaints requiring referral to an out of hospital clinic patients will be referred for further assessment to the cardiology clinic and a repeat CT scan may be performed if deemed relevant.
Outcomes of all patients will be examined at 2 years or later using computerized databases. Patients undergoing hospitalization during the follow up period of at least 2-3 years will be contacted by the study staff to obtain further details of the event and hospital findings .
An analysis wil be performed of the value of CT angiography in relation to the traditional risk factors and other available medical data in the prediction of later coronary heart disease and other vascular events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 55 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Type 2 diabtes mellitus, age 55-74 yrs, no known coronary artery disease
Key inclusion criteria (3 listed)
- Type II diabetes mellitus
- No symptoms of coronary heart disease
- At least one additional risk factor for coronary artery disease
Key exclusion criteria (4 listed)
- Known coronary artery disease
- Kidney failure if more than mild
- Allergy to iodinated X-ray contrast media
- Chronic atrial fibrillation
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 |
|---|---|---|
| Imaging study, No interventionAlso: Philips Brilliance 64 computed tomography scannerImaging with coronary computed tomographic angiography | Other | – |
Primary outcome
Death or acute myocardial infarction
Time frame: 7 years
1 secondary outcome
Composite of the primary outcome and the onset of new symptoms of coronary artery disease with proven myocardial ischemia (supported by treadmill, nuclear scan or stress echo findings) or the need for a revascularization procedure.
Time frame: 7 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2015.
- Background: PubMed 16386666Scognamiglio R, Negut C, Ramondo A, Tiengo A, Avogaro A. Detection of coronary artery disease in asymptomatic patients with type 2 diabetes mellitus. J Am Coll Cardiol. 2006 Jan 3;47(1):65-71. doi: 10.1016/j.jacc.2005.10.008. Epub 2005 Dec 9.
- Background: PubMed 15992649Leber AW, Knez A, von Ziegler F, Becker A, Nikolaou K, Paul S, Wintersperger B, Reiser M, Becker CR, Steinbeck G, Boekstegers P. Quantification of obstructive and nonobstructive coronary lesions by 64-slice computed tomography: a comparative study with quantitative coronary angiography and intravascular ultrasound. J Am Coll Cardiol. 2005 Jul 5;46(1):147-54. doi: 10.1016/j.jacc.2005.03.071.
- Derived from this study: PubMed 19246107Halon DA, Dobrecky-Mery I, Gaspar T, Azencot M, Yaniv N, Peled N, Lewis BS. Pulse pressure and coronary atherosclerosis in asymptomatic type 2 diabetes mellitus: a 64 channel cardiac computed tomography analysis. Int J Cardiol. 2010 Aug 6;143(1):63-71. doi: 10.1016/j.ijcard.2009.01.066. Epub 2009 Feb 25.
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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.
David A Halon, MB ChB, FACC study director
Lady Davis Carmel Medical Center
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 Diabetes Mellitus, run by Carmel Medical Center at 1 site in Israel.
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 3 inclusion and 4 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 29 Jul 2015. 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 Israel. 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?
Death or acute myocardial infarction (time frame: 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00321542, which also lists 3 linked publications.
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 29 Jul 2015.