Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2025-12-26 @ 1:36 AM
Study NCT ID:
NCT00247533
Status:
UNKNOWN
Last Update Posted:
2009-02-09
First Post:
2005-10-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cerebral Artery Stenosis, Coronary Artery Disease and Arrhythmia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D002537', 'term': 'Intracranial Arteriosclerosis'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-08', 'completionDateStruct': {'date': '2007-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-02-06', 'studyFirstSubmitDate': '2005-10-31', 'studyFirstSubmitQcDate': '2005-10-31', 'lastUpdatePostDateStruct': {'date': '2009-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-11-02', 'type': 'ESTIMATED'}}, 'conditionsModule': {'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'], 'conditions': ['Stroke', 'Coronary Artery Disease', 'Arrhythmia']}, 'descriptionModule': {'briefSummary': '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.\n\nIn 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.\n\nFurthermore, 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Coronary artery stenosis \\>50% and either carotid or brain artery stenosis \\> 50%\n\nExclusion Criteria:\n\n* Creatinine \\> 2.0 mg/dL\n* Co-morbidity\n* ER\n* A letter of authorization is not given'}, 'identificationModule': {'nctId': 'NCT00247533', 'briefTitle': 'Cerebral Artery Stenosis, Coronary Artery Disease and Arrhythmia', 'organization': {'class': 'OTHER', 'fullName': 'Far Eastern Memorial Hospital'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'FEMH-E-940004'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Digital subtraction angiography and 24-hour simultaneous recorder of electrocardiograph', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '220', 'city': 'Taipei', 'state': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'A H Li, MD', 'role': 'CONTACT', 'email': 'las1012.tw@yahoo.com.tw', 'phone': '886-2-8966-7000', 'phoneExt': '1113'}, {'name': 'A H Li, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Far Eastern Memorial Hospital'}], 'centralContacts': [{'name': 'A H Li, MD', 'role': 'CONTACT', 'email': 'las1012.tw@yahoo.com.tw', 'phone': '886-2-8966-7000', 'phoneExt': '1113'}], 'overallOfficials': [{'name': 'A H Li, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Far Eastern Memorial Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Far Eastern Memorial Hospital', 'class': 'OTHER'}}}}