Assessment of Coronary Artery Disease in Stroke Patients

Coronary Artery Disease Clinical Trial

— ACADIS  

Official title:

Prevalence and Characteristics of Coronary Atherosclerosis in Stroke Patients Using Coronary CT Angiography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01850693
• Other study ID #: NRF 2010-0023504
• Status: Completed
• Phase: N/A
• First received: May 3, 2013
• Last updated: November 8, 2015
• Start date: July 2006
• Est. completion date: June 2015

Study information

• Verified date: May 2013
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1657
• Est. completion date: June 2015
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	National Reserch Foundation of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Repeated stroke	newly developed stroke after CCTA scan	Participants will be followed until June. 2015, an expeded average of 5 years	No
Primary	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	No
Secondary	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	No