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NCT01142973 Clinical Trial

The Clinical Course of Coronary Artery Disease in Coronary Multidetector Computed Tomographic Angiogram

Coronary Artery Disease Clinical Trial

— PREDICT  

Official title:
Prognostic Role of Coronary Artery plaquEs in Patients With Suspected Coronary Artery Disease Using Multislice of Computed Tomography (PREDICT)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01142973
Other study ID # mdksu-mdct-001
Secondary ID
Status Recruiting
Phase N/A
First received June 11, 2010
Last updated September 10, 2010
Start date September 2005
Est. completion date December 2010

Study information
Verified date September 2010
Source Inje University
Contact Sung Uk Kwon, M.D.
Phone 82-31-910-7041
Email prof.mdksu@gmail.com
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Observational

Clinical Trial Summary

Study Type: Observational Study Design: Observational Model: Defined Population Observational Model: Natural History Time Perspective: Longitudinal Time Perspective: Prospective

Description:

The natural history of individual plaques is unknown and needs to be established. Multidetector computed tomography (MDCT) angiography is a useful noninvasive imaging modality for assessing coronary plaque. Using MDCT, the researchers prospectively investigate the relationship between the presence of coronary plaques and cardiovascular events

Recruitment information / eligibility
Status Recruiting
Enrollment 5000
Est. completion date December 2010
Est. primary completion date August 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- Patients with known or suspected coronary artery disease

Exclusion Criteria:

- Irregular heart beat

- Known allergy towards the contrast agent

- Renal dysfunction

- Impossible breath-hold

- Acute coronary syndrome patient

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Ilsan Paik hospital Goyang

Sponsors (1)
Lead Sponsor Collaborator
Inje University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Major cardiovascular events Cardiovascular death, non-fatal MI, or any stroke 1 years after the MDCT-scan No
Secondary all causes of hospitalization Requiring hospitalization 1 years after the MDCT-scan No
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