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

Type 2 Diabetes Clinical Trial

Official title:

Association of Carotid IMT and Large-vessel Atherosclerosis by MDCT in Korean Type 2 Diabetic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00949169
• Other study ID #: Eulji07-34
• Status: Completed
• Phase: N/A
• First received: July 29, 2009
• Last updated: July 29, 2009
• Start date: April 2006
• Est. completion date: July 2007

Study information

• Verified date: July 2009
• Source: Eulji University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Atherosclerosis
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Locations

Country	Name	City	State
Korea, Republic of	Eulji University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Eulji University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		17 months	No
Secondary	We performed invasive coronary angiography in some patients (N=14) and analyzed association for degrees of CAD between two angiographic methods.		17 months	No