Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2025-12-27 @ 11:25 PM
Study NCT ID:
NCT05344794
Status:
UNKNOWN
Last Update Posted:
2023-02-21
First Post:
2022-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relationship Between Serum N/OFQ and Brain-heart Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'targetDuration': '3 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-17', 'studyFirstSubmitDate': '2022-04-18', 'studyFirstSubmitQcDate': '2022-04-18', 'lastUpdatePostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'N/OFQ', 'timeFrame': '24 hours', 'description': 'Serum N/OFQ levels'}, {'measure': 'IL-6', 'timeFrame': '24 hours', 'description': 'Serum IL-6 levels'}, {'measure': 'NE', 'timeFrame': '24 hours', 'description': 'Serum NE levels'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cerebral-Cardiac Syndrome']}, 'descriptionModule': {'briefSummary': 'Choosing the neurology patients in the Second Hospital of Shanxi Medical University, diagnosed with patients with cerebral syndrome into the experimental group; patients who did not have cerebral syndrome included in the control group, and all selected people had no intimate relationship with each other.Specimen collecting control group and the study group serum inflammatory factor IL-6, solvent peptide and catecholamine content. The difference between the two groups of data was observed.According to the literature, it is guess: The solitary peptide content of the experimental group will be higher than the control group, and is positively correlated with IL-6, catecholamine content.The difference was statistically significant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients in the Second Hospital of Shanxi Medical University from May 2022 to October 2023', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnostic criteria in compliance with cerebral syndrome\n* Acute ischemic stroke patients in line with the "Chinese Acute Ischemic Stroke Treatment Guide 2018" related diagnostic criteria\n* There is no intimate relationship between all selected people and knows this study, and signs informed consent\n\nExclusion Criteria:\n\n* Heart-type cerebral infarction, hemorrhagic stroke, brain tumor and past intracranial hemorrhage\n* Complicated with severe cardiovascular complications (such as coronary heart disease, acute coronary syndrome, acute myocardial infarction, chronic heart failure, atrial fibrillation, etc.)\n* Complicated with severe liver and kidney dysfunction (such as coagulous dysfunction, cirrhosis, nephrotic syndrome , Renal failure, etc.)\n* Complicated with severe diabetes complications (such as diabetic nephropathy, diabetic foot, diabetic acidosis, high blood sugar hypertonic state, diabetes coronary heart disease, etc.)\n* Complicated with Psychological disease\n* Complicated with chronic obstructive pulmonary disease(COPD)\n* BMI\\> 40'}, 'identificationModule': {'nctId': 'NCT05344794', 'briefTitle': 'Relationship Between Serum N/OFQ and Brain-heart Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Second Hospital of Shanxi Medical University'}, 'officialTitle': 'Relationship Between Serum N/OFQ and Cerebral Cardiac Syndrome After Stroke', 'orgStudyIdInfo': {'id': 'hanyi20220418'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CCS group', 'description': 'Patients with cerebral syndrome diagnosed by the Second Hospital of Shanxi Medical University', 'interventionNames': ['Diagnostic Test: Enzyme-linked immunosorbent assay']}, {'label': 'Control group', 'description': 'Patients who have not had a cerebral syndrome in ischemic stroke', 'interventionNames': ['Diagnostic Test: Enzyme-linked immunosorbent assay']}], 'interventions': [{'name': 'Enzyme-linked immunosorbent assay', 'type': 'DIAGNOSTIC_TEST', 'description': 'Serum N/OFQ , IL-6 and NE levels were detected.', 'armGroupLabels': ['CCS group', 'Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '030001', 'city': 'Taiyuan', 'state': 'Shanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'zheng Guo', 'role': 'CONTACT', 'email': '13753171979@163.com', 'phone': '13753171979'}], 'facility': 'Second of Shanxi Medical University', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zheng Guo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Zheng Guo', 'investigatorAffiliation': 'Second Hospital of Shanxi Medical University'}}}}