NCT00431717

Brief Summary

The purpose of this study is to compare the difference of diagnostic efficiency between coronary CT angiography and myocardial perfusion single photon emission computerized tomography 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
116

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2006

Shorter than P25 for all trials

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
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

August 25, 2008

Status Verified

August 1, 2008

Enrollment Period

10 months

First QC Date

February 5, 2007

Last Update Submit

August 22, 2008

Conditions

Coronary AtherosclerosisDiabetes Mellitus

Keywords

Coronary AtherosclerosisDiabetes Mellitus

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Asymptomtaic type 2 diabetes mellitus with multiple risk factors

You may qualify if:

  • Type 2 diabetes mellitus
  • Age 50 \~ 75 years
  • Duration of diabetes: more than 5 years
  • More than two of the following risk factors in addition to diabetes:
  • )dyslipidemia, 2)hypertension, 3)smoking, 4)family history of premature coronary artery disease

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

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
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 5, 2007

First Posted

February 6, 2007

Study Start

November 1, 2006

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

August 25, 2008

Record last verified: 2008-08

Locations

KR(1)