Carotid Intima-media Thickness (IMT) and Large-vessel Atherosclerosis by Multidetector Computed Tomography (MDCT)

This study has been completed.
Sponsor:
Information provided by:
Eulji University Hospital
ClinicalTrials.gov Identifier:
NCT00949169
First received: July 29, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  Purpose

The aim of this study was to investigate whether carotid IMT can predict the presence of more advanced atherosclerosis such as carotid stenosis, coronary or intracranial artery disease by MDCT and whether MDCT could be useful next step for more aggressive treatment modality in Korean type 2 diabetic patients.


Condition
Type 2 Diabetes

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Association of Carotid IMT and Large-vessel Atherosclerosis by MDCT in Korean Type 2 Diabetic Patients

Resource links provided by NLM:


Further study details as provided by Eulji University Hospital:

Primary Outcome Measures:
  • We compared prevalence of large artery stenosis according to carotid IMT group and evaluated whether maximal IMT ≥ 1.0 mm could predict for significant CAD by MDCT. [ Time Frame: 17 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • We performed invasive coronary angiography in some patients (N=14) and analyzed association for degrees of CAD between two angiographic methods. [ Time Frame: 17 months ] [ Designated as safety issue: No ]

Enrollment: 71
Study Start Date: April 2006
Study Completion Date: July 2007
Groups/Cohorts
Carrotid IMT group according to maximal IMT
We defined increased IMT group as whom had maximal IMT ≥ 1.0 mm.

Detailed Description:

We evaluated mean/maximal carotid IMT in seventy-one type 2 diabetic subjects, and defined increased carotid IMT as maximal IMT ≥ 1.0 mm. Multidetector CT (MDCT) and pulse wave velocity (PWV) were taken to evaluate carotid artery stenosis (CS), coronary artery disease (CAD), intracranial arterial lesion (ICA), and peripheral artery disease (PAD). We compared prevalence of large artery stenosis according to carotid IMT group and evaluated whether maximal IMT ≥ 1.0 mm could predict for significant CAD by MDCT. We performed invasive coronary angiography in some patients (N=14) and analyzed association for degrees of CAD between two angiographic methods.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

type 2 diabetic patients who had multiple cardiovascular risk factors

Criteria

Inclusion Criteria:

  • Type 2 diabetic patients who had multiple cardiovascular risk factors were recruited.
  • Patients who had atypical chest pain, EKG abnormality (ischemic ST-T changes or abnormal Q-wave), or history of previous cardiovascular disease were also included.

Exclusion Criteria:

  • Acute coronary SD, serum Cr>1.4 mg/dL, history of allergy to iodinated contrast dye were excluded.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00949169

Locations
Korea, Republic of
Eulji University Hospital
Seoul, Korea, Republic of, 139-711
Sponsors and Collaborators
Eulji University Hospital
Investigators
Principal Investigator: Kyung Wan Min, MD., PhD. Department of Internal Medicine, Eulji University Hospital
  More Information

No publications provided

Responsible Party: Department of Internal Medicine, Eulji University Hospital
ClinicalTrials.gov Identifier: NCT00949169     History of Changes
Other Study ID Numbers: Eulji07-34
Study First Received: July 29, 2009
Last Updated: July 29, 2009
Health Authority: Korea: Food and Drug Administration

Keywords provided by Eulji University Hospital:
Atherosclerosis
Carotid IMT
Multidetector CT
Type 2 diabetes

Additional relevant MeSH terms:
Atherosclerosis
Diabetes Mellitus
Diabetes Mellitus, Type 2
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 23, 2014