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Coronary CT Angiography in Asymptomatic Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT00321542
Recruitment Status : Unknown
Verified February 2015 by Carmel Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : May 3, 2006
Last Update Posted : July 29, 2015
European Foundation for the Study of Diabetes
Information provided by (Responsible Party):
Carmel Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Other: Imaging study, No intervention Phase 3

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 Type : Observational
Actual Enrollment : 793 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : September 2006
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Other: Imaging study, No intervention
    Imaging with coronary computed tomographic angiography
    Other Name: Philips Brilliance 64 computed tomography scanner

Primary Outcome Measures :
  1. Death or acute myocardial infarction [ Time Frame: 7 years ]

Secondary Outcome Measures :
  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. [ Time Frame: 7 years ]

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Ages Eligible for Study:   55 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Type 2 diabtes mellitus, age 55-74 yrs, no known coronary artery disease

Inclusion Criteria:

  • Type II diabetes mellitus
  • No symptoms of coronary heart disease
  • At least one additional risk factor for coronary artery disease

Exclusion Criteria:

  • Known coronary artery disease
  • Kidney failure if more than mild
  • Allergy to iodinated X-ray contrast media
  • Chronic atrial fibrillation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00321542

Lady Davis Carmel Medical Center
Haifa, Israel, 34362
Sponsors and Collaborators
Carmel Medical Center
European Foundation for the Study of Diabetes
Study Director: David A Halon, MB ChB, FACC Lady Davis Carmel Medical Center