Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2025-12-25 @ 12:56 PM
Study NCT ID:
NCT00123695
Status:
UNKNOWN
Last Update Posted:
2008-03-27
First Post:
2005-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serial Echocardiography After Subarachnoid Hemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}, {'id': 'D017682', 'term': 'Myocardial Stunning'}, {'id': 'D054549', 'term': 'Takotsubo Cardiomyopathy'}], 'ancestors': [{'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'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': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D018487', 'term': 'Ventricular Dysfunction, Left'}, {'id': 'D018754', 'term': 'Ventricular Dysfunction'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-03', 'completionDateStruct': {'date': '2008-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-03-26', 'studyFirstSubmitDate': '2005-07-21', 'studyFirstSubmitQcDate': '2005-07-21', 'lastUpdatePostDateStruct': {'date': '2008-03-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-07-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Subarachnoid hemorrhage', 'Takotsubo cardiomyopathy', 'Cardiac abnormalities', 'outcome'], 'conditions': ['Subarachnoid Hemorrhage', 'Myocardial Stunning', 'Takotsubo Cardiomyopathy']}, 'referencesModule': {'references': [{'pmid': '25714519', 'type': 'DERIVED', 'citation': 'van der Bilt IA, Hasan D, van den Brink RB, Cramer MJ, van der Jagt M, van Kooten F, Regtien JG, van den Berg MP, Groen RJ, Cate FJ, Kamp O, Gotte MJ, Horn J, Girbes AR, Vandertop WP, Algra A, Rinkel GJ, Wilde AA; SEASAH (Serial Echocardiography After Subarachnoid Hemorrhage) Investigators. Time course and risk factors for myocardial dysfunction after aneurysmal subarachnoid hemorrhage. Neurosurgery. 2015 Jun;76(6):700-5; discussion 705-6. doi: 10.1227/NEU.0000000000000699.'}]}, 'descriptionModule': {'briefSummary': 'There is increasing interest in myocardial abnormalities following central nervous system events, such as subarachnoid hemorrhage (SAH). These cardiac abnormalities include ECG changes, decreased cardiac output, decreased blood pressure, specific cardiac enzyme elevations, and segmental wall motion abnormalities (SWMA). Interestingly, wall motion abnormalities and ECG changes have shown to be reversible, and therefore the dysfunction has been described as neurogenic myocardial stunning.\n\nThe pathophysiology of cardiac dysfunction following SAH has not yet been fully elucidated. Many reports (mainly case reports) have been published, but so far no study has investigated the frequency of these abnormalities in a prospective manner, have correlated the occurrence of the different cardiac abnormalities, and have assessed which clinical variables can predict cardiac dysfunction. And only a limited number of studies have related neurological outcome with cardiac dysfunction.', 'detailedDescription': 'Objectives: Therefore, our study objectives are: 1) Assessment of the frequency of myocardial dysfunction (segmental wall motion abnormalities, cardiac-specific enzyme elevations, and ECG changes) in patients with SAH. 2) Determination of predictive clinical variables for the occurrence of myocardial dysfunction following SAH. 3) Impact of myocardial dysfunction on neurological prognosis: death, secondary cerebral ischemia, hydrocephalus and rebleeding.\n\nMethods: For this purpose serial echocardiograms and ECGs will be obtained and cardiac enzymes will be measured in 200-400 patients admitted to hospital with SAH in the four participating centers. The clinical variables that will be studied to predict cardiac dysfunction are: medical history, the CT-scan score, circulatory parameters, blood samples, medication, surgical intervention (coiling or clipping), and the neurological condition (Glasgow Coma Scale). The echocardiograms, ECGs and cardiac enzymes will be studied to determine if they have independent prognostic value for the outcome in SAH patients.\n\nExpected Results: As ECG changes and drops in blood pressure are known to occur frequently, the researchers expect to find that cardiac contractile dysfunction in patients with SAH occurs more frequently than is assumed now. Moreover, if cardiac abnormalities have neurological prognostic significance further studies are needed for early recognition and treatment of the cardiac abnormalities in SAH, a condition with a very poor prognosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosed with aneurysmal subarachnoid hemorrhage\n* Admitted within 72 hours of the bleed\n\nExclusion Criteria:\n\n* No informed consent\n* Patients or patients' family unwillingness to participate"}, 'identificationModule': {'nctId': 'NCT00123695', 'acronym': 'SEAS', 'briefTitle': 'Serial Echocardiography After Subarachnoid Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'Amsterdam UMC, location VUmc'}, 'officialTitle': 'Serial Echocardiography After Subarachnoid Hemorrhage (S.E.A.S.)', 'orgStudyIdInfo': {'id': '04-193'}}, 'contactsLocationsModule': {'locations': [{'zip': '1105AZ', 'city': 'Amsterdam', 'state': 'North Holland', 'country': 'Netherlands', 'facility': 'Academic Medical Center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '1105 AZ', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Academic Medical Center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '9700 RB', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'University Medical Center Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus Medical Center Rotterdam', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '5022 GC', 'city': 'Tilburg', 'country': 'Netherlands', 'facility': 'Saint Elisabeth Hospital', 'geoPoint': {'lat': 51.55551, 'lon': 5.0913}}, {'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'University Medical Center Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}], 'overallOfficials': [{'name': 'Frans C Visser, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Amsterdam UMC, location VUmc'}, {'name': 'Ivo A van der Bilt, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, {'name': 'Gabriel J Rinkel, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMC Utrecht'}, {'name': 'Arthur A Wilde, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amsterdam UMC, location VUmc', 'class': 'OTHER'}, 'collaborators': [{'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}, {'name': 'UMC Utrecht', 'class': 'OTHER'}, {'name': 'University Medical Center Groningen', 'class': 'OTHER'}, {'name': 'Erasmus Medical Center', 'class': 'OTHER'}]}}}