Assessment of Coronary Artery Disease in Stroke Patients (ACADIS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Seoul National University Hospital
Sponsor:
Collaborator:
National Reserch Foundation of Korea
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01850693
First received: May 3, 2013
Last updated: May 6, 2013
Last verified: May 2013
  Purpose

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.


Condition
Coronary Artery Disease

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Prevalence and Characteristics of Coronary Atherosclerosis in Stroke Patients Using Coronary CT Angiography

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • MACE (Major Adverse Cardiac Event) [ Time Frame: Participants will be followed until Dec. 2013, an expeded average of 5 years ] [ Designated as safety issue: No ]
    MACE was included as follows: 1) all-cause mortality, 2) myocardial infarction, 3) unstable angina requiring hospitalization


Secondary Outcome Measures:
  • Revascularization [ Time Frame: Participants will be followed until Dec. 2013, an expeded average of 5 years ] [ Designated as safety issue: No ]
    However, early revascularization less than 90days after CCTA scan is excluded from events, because these subjects directly affected by CT findings


Other Outcome Measures:
  • Repeated stroke [ Time Frame: Participants will be followed until Dec. 2013, an expeded average of 5 years ] [ Designated as safety issue: No ]
    newly developed stroke after CCTA scan


Estimated Enrollment: 2500
Study Start Date: January 2006
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Coronary artery disease, Stroke
Coronary artery disease, stroke, 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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Stroke patients on the basis of TOAST classification

Criteria

Inclusion Criteria:

  • Stroke patients who diagnosed by clinical and brain imaging
  • Who performed coronary CT angiography between 2006 and 2012

Exclusion Criteria:

  • Traumatic brain injury or traumatic stroke patients
  • Previous myocardial infarction or coronary artery disease
  • Previously performed percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or other cardiac surgery
  • Insufficient medical record
  • Poor image quality of CCTA scan
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01850693

Contacts
Contact: Eun Ju Chun, MD +82-31-787-7618 drejchun@daum.net
Contact: Eun Hee Kim, MD +82-31-787-7609 xmida@hanmail.net

Locations
Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 436-707
Contact: Eun Ju Chun, MD    +82-31-787-7618    drejchun@daum.net   
Contact: Eun Hee Kim, MD    +82-31-787-7609    xmida@hanmail.net   
Principal Investigator: Eun Ju Chun, MD         
Sponsors and Collaborators
Seoul National University Hospital
National Reserch Foundation of Korea
Investigators
Principal Investigator: Eun Ju Chun, MD Department of Radiology, Seoul National University Bundang Hospital
  More Information

No publications provided

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01850693     History of Changes
Other Study ID Numbers: NRF 2010-0023504
Study First Received: May 3, 2013
Last Updated: May 6, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
coronary artery disease
stroke
coronary CT angiography

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 19, 2014