The Clinical Course of Coronary Artery Disease in Coronar... | NCT01142973

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

NCT01142973

Sponsor

Inje University

Status

Unknown status

Last Update Posted

Sep 13, 2010Estimated

Enrollment

5,000Estimated

Phase

Not provided

Conditions

Atherosclerosis
Cardiovascular Diseases
Coronary Artery Disease

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2005

Primary Completion Date

Aug 2010Actual

Completion Date

Dec 2010Estimated

First Submitted Date

Jun 11, 2010

First Submission Date that Met QC Criteria

Jun 11, 2010

First Posted Date

Jun 14, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 10, 2010

Last Update Posted Date

Sep 13, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed 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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Major cardiovascular events	Cardiovascular death, non-fatal MI, or any stroke	1 years after the MDCT-scan

Secondary Outcomes

Measure	Description	Time Frame
all causes of hospitalization	Requiring hospitalization	1 years after the MDCT-scan

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

present typical/atypical chest pain

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sung Uk Kwon, M.D.	Contact	82-31-910-7041		prof.mdksu@gmail.com

Overall Officials

Name	Affiliation	Role
Sung Uk Kwon, M.D.	Inje univ. ilsan paik hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ilsan Paik hospital	Recruiting	Goyang			South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24717325	Derived	Kim JB, Rogers IS, Kwon SU. Presence of plaques predicts worse outcomes in multi-detector computed tomography in patients with stable chest pain syndrome. Int J Cardiol. 2014 May 15;173(3):570-2. doi: 10.1016/j.ijcard.2014.03.118. Epub 2014 Mar 21. No abstract available.

ID	Term
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases
D003327	Coronary Disease

ID	Term
D050197	Atherosclerosis
D002318	Cardiovascular Diseases
D003324	Coronary Artery Disease