NCT00321542

Brief Summary

The study aims to examine if non-invasive imaging of the coronary arteries by CT angiography using an intra-venous injection of X-ray contrast medium in asymptomatic patients with adult onset diabetes mellitus can predict the risk of developing coronary heart disease.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
793

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

May 2, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 3, 2006

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

July 29, 2015

Status Verified

February 1, 2015

Enrollment Period

9 years

First QC Date

May 2, 2006

Last Update Submit

July 28, 2015

Conditions

Diabetes Mellitus

Keywords

Computed tomographyDiabetes mellitusCoronary atherosclerosisNon-invasive imaging

Outcome Measures

Primary Outcomes (1)

  • Death or acute myocardial infarction

    7 years

Secondary Outcomes (1)

  • Composite of the primary outcome and the onset of new symptoms of coronary artery disease with proven myocardial ischemia (supported by treadmill, nuclear scan or stress echo findings) or the need for a revascularization procedure.

    7 years

Interventions

Imaging study, No interventionOTHER

Imaging with coronary computed tomographic angiography

Also known as: Philips Brilliance 64 computed tomography scanner

Eligibility Criteria

Age55 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Type 2 diabtes mellitus, age 55-74 yrs, no known coronary artery disease

You may qualify if:

  • Type II diabetes mellitus
  • No symptoms of coronary heart disease
  • At least one additional risk factor for coronary artery disease

You may not qualify if:

  • Known coronary artery disease
  • Kidney failure if more than mild
  • Allergy to iodinated X-ray contrast media
  • Chronic atrial fibrillation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lady Davis Carmel Medical Center

Haifa, 34362, Israel

Location

Related Publications (3)

  • Scognamiglio R, Negut C, Ramondo A, Tiengo A, Avogaro A. Detection of coronary artery disease in asymptomatic patients with type 2 diabetes mellitus. J Am Coll Cardiol. 2006 Jan 3;47(1):65-71. doi: 10.1016/j.jacc.2005.10.008. Epub 2005 Dec 9.

    PMID: 16386666BACKGROUND

  • Leber AW, Knez A, von Ziegler F, Becker A, Nikolaou K, Paul S, Wintersperger B, Reiser M, Becker CR, Steinbeck G, Boekstegers P. Quantification of obstructive and nonobstructive coronary lesions by 64-slice computed tomography: a comparative study with quantitative coronary angiography and intravascular ultrasound. J Am Coll Cardiol. 2005 Jul 5;46(1):147-54. doi: 10.1016/j.jacc.2005.03.071.

    PMID: 15992649BACKGROUND

  • Halon DA, Dobrecky-Mery I, Gaspar T, Azencot M, Yaniv N, Peled N, Lewis BS. Pulse pressure and coronary atherosclerosis in asymptomatic type 2 diabetes mellitus: a 64 channel cardiac computed tomography analysis. Int J Cardiol. 2010 Aug 6;143(1):63-71. doi: 10.1016/j.ijcard.2009.01.066. Epub 2009 Feb 25.

    PMID: 19246107DERIVED

MeSH Terms

Conditions

Diabetes MellitusCoronary Artery Disease

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • David A Halon, MB ChB, FACC

    Lady Davis Carmel Medical Center

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2006

First Posted

May 3, 2006

Study Start

September 1, 2006

Primary Completion

September 1, 2015

Study Completion

September 1, 2017

Last Updated

July 29, 2015

Record last verified: 2015-02

Locations

IL(1)