Assessment of Coronary Artery Disease in Stroke Patients | NCT01850693

Studies
Assessment of Coronary Artery Disease in Stroke Patients

NCT01850693

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Nov 10, 2015Estimated

Enrollment

1,657Actual

Phase

Not provided

Conditions

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

May 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2006

Primary Completion Date

Dec 2012Actual

Completion Date

Jun 2015Actual

First Submitted Date

May 3, 2013

First Submission Date that Met QC Criteria

May 6, 2013

First Posted Date

May 9, 2013Estimated

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

Nov 8, 2015

Last Update Posted Date

Nov 10, 2015Estimated

Name	Class
National Research Foundation of Korea	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

This study is to evaluate the prevalence, plaque characteristics (plaque types, stenosis degree, remodeling) and predictors of coronary atherosclerosis in stroke patients with coronary CT angiography.

Detailed Description

Stroke and coronary artery disease (CAD) share common risk factors and pathological mechanisms. CAD is an important cause of death in patients with stroke.

Currently, coronary CT angiography (CCTA) is very useful non-invasive tool for detection of CAD and plaque analysis.

Therefore, the investigators aimed to evaluate the prevalence, plaque characteristics (plaque types, stenosis degree, remodeling) and predictors of CAD in stroke patients through follow-up (more than 5 years) using CCTA.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,657Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Coronary artery disease, Stroke		Coronary artery disease, stroke, coronary CT angiography

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
MACE (Major Adverse Cardiac Event)	MACE was included as follows: 1) all-cause mortality, 2) myocardial infarction, 3) unstable angina requiring hospitalization	Participants will be followed until June. 2015, an expeded average of 5 years

Secondary Outcomes

Measure	Description	Time Frame
Any cardiac events	1) late revascularization: who underwent revascularization therapy mroe than 90days after CCTA and referral due ot new symptoms or an abnormal function test, 2) heart failure required hospitalization.	Participants will be followed until June. 2015, an expeded average of 5 years

Other Outcomes

Measure	Description	Time Frame
Repeated stroke	newly developed stroke after CCTA scan	Participants will be followed until June. 2015, an expeded average of 5 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Acute stroke patients who diagnosed by clinical and brain MR imaging
Who performed coronary CT angiography within 3 months after acute stroke

Exclusion Criteria:

intracranial hemorrhage including intracerebral, subdural or subarachnoid hemorrhage
brain tumor
Previous myocardial infarction
Previously performed percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or other cardiac surgery
Insufficient medical record
Poor image quality of CCTA scan

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Stroke patients on the basis of TOAST classification

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eun Ju Chun, MD	Department of Radiology, Seoul National University Bundang Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital		Seongnam-si	Gyeonggi-do	436-707	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease
D020521	Stroke

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided