NCT01850693

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,657

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2006

Longer than P75 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

July 1, 2006

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 9, 2013

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

November 10, 2015

Status Verified

May 1, 2013

Enrollment Period

6.4 years

First QC Date

May 3, 2013

Last Update Submit

November 8, 2015

Conditions

Coronary Artery Disease

Keywords

coronary artery diseasestrokecoronary CT angiography

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Any cardiac events

    Participants will be followed until June. 2015, an expeded average of 5 years

Other Outcomes (1)

  • Repeated stroke

    Participants will be followed until June. 2015, an expeded average of 5 years

Study Arms (1)

Coronary artery disease, Stroke

Coronary artery disease, stroke, coronary CT angiography

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Stroke patients on the basis of TOAST classification

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 436-707, South Korea

Location

MeSH Terms

Conditions

Coronary Artery DiseaseStroke

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Eun Ju Chun, MD

    Department of Radiology, Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2013

First Posted

May 9, 2013

Study Start

July 1, 2006

Primary Completion

December 1, 2012

Study Completion

June 1, 2015

Last Updated

November 10, 2015

Record last verified: 2013-05

Locations

KR(1)