Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-02-10 @ 3:53 AM
Study NCT ID:
NCT02991157
Status:
COMPLETED
Last Update Posted:
2019-03-26
First Post:
2016-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Noninvasive Assessment of Cerebral Oxygenation and Cardiac Function in Patients With Neurovascular Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}, {'id': 'D020301', 'term': 'Vasospasm, Intracranial'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009553', 'term': 'Nimodipine'}], 'ancestors': [{'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009539', 'term': 'Nicotinic Acids'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-23', 'studyFirstSubmitDate': '2016-12-07', 'studyFirstSubmitQcDate': '2016-12-09', 'lastUpdatePostDateStruct': {'date': '2019-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the cerebral oxygen saturation percentage measured using near infrared spectroscopy technology after administration of nimodipine', 'timeFrame': 'Change from baseline cerebral oxygen saturation at 30 minutes after administration of nimodipine'}], 'secondaryOutcomes': [{'measure': 'Change in the cardiac output measured using near NICOM technology after administration of nimodipine', 'timeFrame': 'Change from baseline cardiac output at 30 and 240 minutes after administration of nimodipine', 'description': 'unit of measurement will be L/min'}, {'measure': 'Change in the cerebral oxygen saturation percentage measured using near infrared spectroscopy technology after administration of nimodipine', 'timeFrame': 'Change from baseline cerebral oxygen saturation at 240 minutes after administration of nimodipine'}]}, 'conditionsModule': {'keywords': ['cerebral vasospasm', 'nimodipine'], 'conditions': ['Subarachnoid Hemorrhage, Aneurysmal']}, 'descriptionModule': {'briefSummary': 'This prospective observational study will assess the regional cerebral oxygen saturation and cardiac output non-invasively in patients with subarachnoid hemorrhage during nimodipine administration for the prevention/management of cerebral vasospasm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'aneurysmal subarachnoid hemorrhage with cerebral vasospasm', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aneurysmal subarachnoid hemorrhage\n* potential or actual cerebral vasospasm\n\nExclusion Criteria:\n\n* non-aneurysmal subarachnoid hemorrhage\n* outside the 4-21 day window after ictus\n* peripheral deoxygenation\n* contraindication for nimodipine administration'}, 'identificationModule': {'nctId': 'NCT02991157', 'briefTitle': 'Noninvasive Assessment of Cerebral Oxygenation and Cardiac Function in Patients With Neurovascular Diseases', 'organization': {'class': 'OTHER', 'fullName': 'National Institute of Mental Health and Neuro Sciences, India'}, 'officialTitle': 'Noninvasive Assessment of Cerebral Oxygenation and Cardiac Function in Patients With Neurovascular Diseases', 'orgStudyIdInfo': {'id': '12.02'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Nimodipine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bengaluru', 'country': 'India', 'facility': 'NIMHANS', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Mental Health and Neuro Sciences, India', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Sriganesh Kamath', 'investigatorAffiliation': 'National Institute of Mental Health and Neuro Sciences, India'}}}}