Assessment of Coronary Artery Disease in Stroke Patients (ACADIS)

This study has been completed.
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: November 8, 2015
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
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 ] [ 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:
  • Any cardiac events [ Time Frame: Participants will be followed until June. 2015, an expeded average of 5 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   30 Years and older   (Adult, Senior)
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:

  • 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
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

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 Reserch 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 
Study First Received: May 3, 2013
Last Updated: November 8, 2015
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 July 28, 2016