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Assessment of Coronary Artery Disease in Stroke Patients (ACADIS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01850693
First Posted: May 9, 2013
Last Update Posted: November 10, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Research Foundation of Korea
Information provided by (Responsible Party):
Seoul National University Hospital
  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
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 June. 2015, an expeded average of 5 years ]
    MACE was included as follows: 1) all-cause mortality, 2) myocardial infarction, 3) unstable angina requiring hospitalization


Secondary Outcome Measures:
  • Any cardiac events [ Time Frame: Participants will be followed until June. 2015, an expeded average of 5 years ]
    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.


Other Outcome Measures:
  • Repeated stroke [ Time Frame: Participants will be followed until June. 2015, an expeded average of 5 years ]
    newly developed stroke after CCTA scan


Enrollment: 1657
Study Start Date: July 2006
Study Completion Date: June 2015
Primary Completion Date: December 2012 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Stroke patients on the basis of TOAST classification
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01850693


Locations
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of, 436-707
Sponsors and Collaborators
Seoul National University Hospital
National Research Foundation of Korea
Investigators
Principal Investigator: Eun Ju Chun, MD Department of Radiology, Seoul National University Bundang Hospital
  More Information

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01850693     History of Changes
Other Study ID Numbers: NRF 2010-0023504
First Submitted: May 3, 2013
First Posted: May 9, 2013
Last Update Posted: November 10, 2015
Last Verified: May 2013

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