NCT00949169

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

July 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 30, 2009

Completed
Last Updated

July 30, 2009

Status Verified

July 1, 2009

First QC Date

July 29, 2009

Last Update Submit

July 29, 2009

Conditions

Keywords

AtherosclerosisCarotid IMTMultidetector CTType 2 diabetes

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • We performed invasive coronary angiography in some patients (N=14) and analyzed association for degrees of CAD between two angiographic methods.

    17 months

Study Arms (1)

Carrotid IMT group according to maximal IMT

We defined increased IMT group as whom had maximal IMT ≥ 1.0 mm.

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

type 2 diabetic patients who had multiple cardiovascular risk factors

You may qualify if:

  • 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.

You may not qualify if:

  • Acute coronary SD, serum Cr\>1.4 mg/dL, history of allergy to iodinated contrast dye were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eulji University Hospital

Seoul, 139-711, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Atherosclerosis

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Kyung Wan Min, MD., PhD.

    Department of Internal Medicine, Eulji University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 29, 2009

First Posted

July 30, 2009

Study Start

April 1, 2006

Study Completion

July 1, 2007

Last Updated

July 30, 2009

Record last verified: 2009-07

Locations