Coronary CT Angiography in Asymptomatic 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.
|Study Design:||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|
- Death or acute myocardial infarction [ Time Frame: 7 years ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||September 2006|
|Estimated Study Completion Date:||September 2016|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Other: Imaging study, No intervention
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 events.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00321542
|Lady Davis Carmel Medical Center|
|Haifa, Israel, 34362|
|Principal Investigator:||Tamar Gaspar, MD||Lady Davis Carmel Medical Center|
|Principal Investigator:||Nathan Peled, MD||Lady Davis Carmel Medical Center|
|Principal Investigator:||David A Halon, MB ChB, FACC||Lady Davis Carmel Medical Center|