Clinical trial NCT00247533: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: 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
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2005-11-02
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Far Eastern Memorial Hospital
Study officials:
affiliation: Far Eastern Memorial Hospital
name: A H Li, MD
role: PRINCIPAL_INVESTIGATOR
References: