Coronary CT Angiography in Asymptomatic Diabetes Mellitus

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
European Foundation for the Study of Diabetes
Information provided by (Responsible Party):
Carmel Medical Center
ClinicalTrials.gov Identifier:
NCT00321542
First received: May 2, 2006
Last updated: November 24, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Diabetes Mellitus
Other: Imaging study, No intervention
Phase 3

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Carmel Medical Center:

Primary Outcome Measures:
  • Death or acute myocardial infarction [ Time Frame: 7 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 793
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)
Intervention Details:
    Other: Imaging study, No intervention
    Imaging with coronary computed tomographic angiography
    Other Name: Philips Brilliance 64 computed tomography scanner
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 events.

  Eligibility

Ages Eligible for Study:   55 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Type 2 diabtes mellitus, age 55-74 yrs, no known coronary artery disease

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00321542

Locations
Israel
Lady Davis Carmel Medical Center
Haifa, Israel, 34362
Sponsors and Collaborators
Carmel Medical Center
European Foundation for the Study of Diabetes
Investigators
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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Carmel Medical Center
ClinicalTrials.gov Identifier: NCT00321542     History of Changes
Other Study ID Numbers: CT-DM
Study First Received: May 2, 2006
Last Updated: November 24, 2013
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Carmel Medical Center:
Computed tomography
Diabetes mellitus
Coronary atherosclerosis
Non-invasive imaging

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 28, 2014