Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2026-04-17 @ 7:56 AM
Study NCT ID:
NCT02974192
Status:
UNKNOWN
Last Update Posted:
2017-01-18
First Post:
2016-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neopterin Effects on Ischemic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019798', 'term': 'Neopterin'}], 'ancestors': [{'id': 'D001708', 'term': 'Biopterins'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-01-14', 'studyFirstSubmitDate': '2016-11-23', 'studyFirstSubmitQcDate': '2016-11-25', 'lastUpdatePostDateStruct': {'date': '2017-01-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neopterin level', 'timeFrame': 'Within the first 24 hours', 'description': 'will be measured by using standard laboratory methods on the first day of admission'}, {'measure': 'Soluble CD40 Ligand', 'timeFrame': 'Within the first 24 hours', 'description': 'will be measured by using standard laboratory methods on the first day of admission'}], 'secondaryOutcomes': [{'measure': 'Stroke subtype', 'timeFrame': 'Within the first 24 hours', 'description': 'will be classified according to the criteria of Trial of Org 10172 in acute Stroke Treatment (TOAST) classification'}, {'measure': 'The clinical stroke syndrome', 'timeFrame': 'Within the first 24 hours', 'description': 'will be determined by applying the criteria of the Oxfordshire Community Stroke project (OCSP)'}, {'measure': 'Stroke severity', 'timeFrame': 'Within the first 24 hours', 'description': 'Stroke severity will be assessed by Scandinavian Stroke Scale (SSS) and Modified Rankin Scale (mRS) will be measured at the time of admission.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Ischemic stroke', 'Soluble CD40 Ligand', 'Neopetrin', 'stroke risk factors', 'functional outcome'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'Ischemic stroke accounts for the majority of stroke cases and constitutes a major cause of death and disability in industrial world. Inflammation has been reported to constitute a major component of ischemic stroke pathology. The brain responds to ischemic injury with an acute andprolonged inflammatory process. Few studies have investigated the relationship between acute biomarkers of inflammation and functional outcome following stroke', 'detailedDescription': 'This case -control observational prospective study will be conducted on 100 patients with first -ever acute onset ischemic stroke within 24-48 hours. Their ages ranged-years old (mean age ±years). All participants will be subjected to thorough history taking, full clinical and neurological examination. Complete neurological examination where the following clinical and demographical data will be taken; age sex, stroke etiology, presence of stroke risk factors (as smoking history , hyperlipidemia, diabetes mellitus , history of hypertension, history of transient ischemic attacks, history of myocardial infarction or any cardiac problems). Stroke subtype will be classified according to the criteria of Trial of Org 10172 in acute Stroke Treatment (TOAST) classification. The clinical stroke syndrome will be determined by applying the criteria of the Oxfordshire Community Stroke project (OCSP). Stroke severity will be assessed by Scandinavian Stroke Scale (SSS) and Modified Rankin Scale (mRS) will be measured at the time of admission. Brain imaging (either CT scan and /or MRI) will be performed after admission. Electrocardiography (ECG), Echocardiography (ECHO), Carotid and vertibrobasilar Duplex will be done for all patients. Blood samples will be drawn for assessment of complete blood picture (CBC), Random blood glucose levels, renal function tests (RFT), liver function tests (LFT), thyroid function tests (TFT), Lipid profile, Soluble CD40 Ligand and Neopetrin by using standard laboratory methods on the first day of admission.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with first -ever acute onset ischemic stroke within 24-48 hours', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Onset is within one week\n* Confirmed stroke by brain CAT and / or MRI scan infarction\n* Exclusion Criteria:\n* Cognitive and mental changes\n* Recurrent stroke\n* Hepatic and renal impairment\n* Endocrinal diseases\n* Steroid therapy\n* Previous fractures\n* brain neoplasm,\n* Autoimmune diseases\n* History of acute and chronic inflammatory diseases\n* Malignancy,\n* Trauma\n* Surgery\n* Acute vascular diseases that occurred within four weeks prior the onset of stroke History myocardial infarction ˂3 months.'}, 'identificationModule': {'nctId': 'NCT02974192', 'briefTitle': 'Neopterin Effects on Ischemic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Neoptrin, Soluble CD40-ligand and Ischemic Stroke: a Clinical Perspective', 'orgStudyIdInfo': {'id': 'IIRB0000871432'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Neopterin', 'type': 'OTHER', 'description': 'Neopterin will be measured by using standard laboratory methods on the first day of admission.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'state': 'Asyut Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'mohamed abdelatef, MD', 'role': 'CONTACT', 'email': 'latif_mohamed@hotmail.com', 'phone': '0020882413201'}], 'facility': 'Faculty of Medicine', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Sayed K Abd-Elshafy, MD', 'role': 'CONTACT', 'email': 'sayed_k_72@yahoo.com', 'phone': '0020882413203'}], 'overallOfficials': [{'name': 'Sayed k Abd-Elshafy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate professor of anesthesia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate profossor of anesthesia', 'investigatorFullName': 'Sayed Kaoud Abd-Elshafy', 'investigatorAffiliation': 'Assiut University'}}}}