- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00247533
Cerebral Artery Stenosis, Coronary Artery Disease and Arrhythmia
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Taipei, Taiwan, 220
- Recruiting
- Far Eastern Memorial Hospital
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Contact:
- A H Li, MD
- Phone Number: 1113 886-2-8966-7000
- Email: las1012.tw@yahoo.com.tw
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Principal Investigator:
- A H Li, MD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: A H Li, MD, Far Eastern Memorial Hospital
Study record dates
Study Major Dates
Study Start
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- Coronary artery disease
- atrial fibrillation
- coronary disease
- ischemic stroke
- coronary artery bypass surgery
- angiography
- cerebral ischemia
- electroencephalograph
- cerebrovascular disorders
- intracranial atherosclerosis
- cerebral artery stenosis
- percutaneous coronary balloon angioplasty
- electrocardiograph
- Nuclear brain scan
- cognition decline
- undetermined ischemic stroke
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Pathological Conditions, Anatomical
- Stroke
- Coronary Artery Disease
- Myocardial Ischemia
- Coronary Disease
- Ischemic Stroke
- Arrhythmias, Cardiac
- Constriction, Pathologic
Other Study ID Numbers
- FEMH-E-940004
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