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Cerebral Artery Stenosis, Coronary Artery Disease and Arrhythmia

Primary Purpose

Stroke, Coronary Artery Disease, Arrhythmia

Status
Unknown status
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Digital subtraction angiography and 24-hour simultaneous recorder of electrocardiograph
Sponsored by
Far Eastern Memorial Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Stroke focused on measuring coronary disease, cerebrovascular disorders, angiography, cerebral ischemia, intracranial atherosclerosis, Coronary artery disease, cerebral artery stenosis, percutaneous coronary balloon angioplasty, coronary artery bypass surgery, ischemic stroke, electrocardiograph, electroencephalograph, Nuclear brain scan, cognition decline, atrial fibrillation, undetermined ischemic stroke

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Coronary artery stenosis >50% and either carotid or brain artery stenosis > 50% Exclusion Criteria: Creatinine > 2.0 mg/dL Co-morbidity ER A letter of authorization is not given

Sites / Locations

  • Far Eastern Memorial HospitalRecruiting

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 31, 2005
Last Updated
February 6, 2009
Sponsor
Far Eastern Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00247533
Brief Title
Cerebral Artery Stenosis, Coronary Artery Disease and Arrhythmia
Official Title
The Early Diagnosis and Prevention of Ischemic Stroke and Cognition Decline Associated With Coronary Artery Disease Combined With Cerebral Artery Stenosis or Arrhythmia by 24-Hour Simultaneous Recorder of Electrocardiograph and Electroencephalography
Study Type
Interventional

2. Study Status

Record Verification Date
August 2005
Overall Recruitment Status
Unknown status
Study Start Date
October 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Far Eastern Memorial Hospital

4. Oversight

5. Study Description

Brief Summary
There are many reports about the association of coronary artery disease (CAD) and cerebral artery stenosis (CAS), which had been proved to induce stroke and cognition decline after the revascularization including coronary bypass surgery (CABG) or percutaneous coronary intervention. Perfusion defect on nuclear brain scan is also noted to correlate with these neurological complications. On the other hand, the perioperative arrhythmia and following cerebral embolism was also attributed to be one factor inducing such neurological hazards. In the patients with coexistent CAD and CAS (1st group), and also the patients scheduled for CABG or percutaneous coronary intervention (PCI) (2nd group), we, the researchers at Far Eastern Memorial Hospital, attempted to integrate all the parameters mention above, including angiography of coronary and cerebral system, quantitative analysis of nuclear brain scan, biochemical profile, and signals of a new ambulatory device which could record the electrocardiograph (ECG) and electroencephalograph (EEG) simultaneously, in order to define the correlation between them. A chorological relation between EEG signals and ECG signals is our first target to be worked out. Thereafter, we hope to establish a regression model of all involved parameters according to the relation. Such a model, we believe, is essential not only to explain the post-CABG neurological complications, but to prevent them. Furthermore, for the undetermined ischemic stroke patients who had no obvious culprit artery or embolism source, the paroxysmal arrhythmia had long been regarded as the cause. Whether a paroxysmal atrial fibrillation, which had not been disclosed by routine ECG, could induce most of such a stroke is still not known. With this new ambulatory device which could record the electrocardiograph (ECG) and electroencephalograph (EEG) simultaneously, we want to answer the question.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Coronary Artery Disease, Arrhythmia
Keywords
coronary disease, cerebrovascular disorders, angiography, cerebral ischemia, intracranial atherosclerosis, Coronary artery disease, cerebral artery stenosis, percutaneous coronary balloon angioplasty, coronary artery bypass surgery, ischemic stroke, electrocardiograph, electroencephalograph, Nuclear brain scan, cognition decline, atrial fibrillation, undetermined ischemic stroke

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Digital subtraction angiography and 24-hour simultaneous recorder of electrocardiograph

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Coronary artery stenosis >50% and either carotid or brain artery stenosis > 50% Exclusion Criteria: Creatinine > 2.0 mg/dL Co-morbidity ER A letter of authorization is not given
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
A H Li, MD
Phone
886-2-8966-7000
Ext
1113
Email
las1012.tw@yahoo.com.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
A H Li, MD
Organizational Affiliation
Far Eastern Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Far Eastern Memorial Hospital
City
Taipei
ZIP/Postal Code
220
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A H Li, MD
Phone
886-2-8966-7000
Ext
1113
Email
las1012.tw@yahoo.com.tw
First Name & Middle Initial & Last Name & Degree
A H Li, MD

12. IPD Sharing Statement

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Cerebral Artery Stenosis, Coronary Artery Disease and Arrhythmia

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