NCT00431977

Brief Summary

The purpose of this study is to evaluate the prevalence and clinical predictors of subclinical coronary atherosclerosis and to validate the usefulness of coronary CT angiography as a screening tool in asymptomatic patients with type 2 diabetes mellitus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2006

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 6, 2007

Completed
5.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

June 21, 2011

Status Verified

October 1, 2006

First QC Date

February 5, 2007

Last Update Submit

June 20, 2011

Conditions

Coronary AtherosclerosisDiabetes Mellitus

Keywords

Coronary AtherosclerosisDiabetes Mellitus

Outcome Measures

Primary Outcomes (3)

  • Myocardial infarction

  • Late revascularization therapy

  • Cardiac death

Secondary Outcomes (3)

  • Early revascularization therapy

  • Other procedure (i.e. peripheral vascular procedure)

  • All-caused death

Interventions

coronary computed tomography angiographyPROCEDURE

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes mellitus
  • Age 50 \~ 75 years

You may not qualify if:

  • angina pectoris or anginal equivalent symptoms
  • insulin pump user or history of ketoacidosis
  • history of myocardial infarction, heart failure, or coronary revascularization
  • electrocardiographic evidence of Q-wave myocardial infarction, ischemic ST- segment or T-wave changes, or complete left bundle branch block
  • uncontrolled arrythmia
  • hypersensitivity to contrast dye
  • renal failure
  • uncontrolled arrythmia
  • hypersensitivity to contrast dye
  • renal failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang hospital

Sungnam-si, Gyeonggi-do, South Korea

Location

MeSH Terms

Conditions

Coronary Artery DiseaseDiabetes Mellitus

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Huk-Jae Chang, MD, PhD

    Seoul National University Bundang Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 5, 2007

First Posted

February 6, 2007

Study Start

November 1, 2006

Study Completion

December 1, 2012

Last Updated

June 21, 2011

Record last verified: 2006-10

Locations

KR(1)