Ignite Creation Date:
2025-12-24 @ 4:11 PM
Ignite Modification Date:
2025-12-26 @ 1:30 PM
Study NCT ID:
NCT05345366
Status:
COMPLETED
Last Update Posted:
2024-06-06
First Post:
2022-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Correlation Between CITED2 and Collateral Circulation in Acute Ischemic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-04', 'studyFirstSubmitDate': '2022-04-19', 'studyFirstSubmitQcDate': '2022-04-19', 'lastUpdatePostDateStruct': {'date': '2024-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CITED2', 'timeFrame': 'within 24 hours after hospitalization', 'description': 'western blot/ELISA'}, {'measure': 'VEGF', 'timeFrame': 'within 24 hours after hospitalization', 'description': 'western blot/ELISA'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Ischemic Stroke']}, 'referencesModule': {'references': [{'pmid': '36247751', 'type': 'DERIVED', 'citation': 'Lu M, Liu Y, Xian Z, Yu X, Chen J, Tan S, Zhang P, Guo Y. VEGF to CITED2 ratio predicts the collateral circulation of acute ischemic stroke. Front Neurol. 2022 Sep 30;13:1000992. doi: 10.3389/fneur.2022.1000992. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'Evaluating the collateral circulation of acute ischemic stroke (AIS) mainly depends on the imaging examination. At present, there is no effective and sensitive biomarker for collateral circulation. Thus, the research objective was to evaluate the predicting role of the CBP/P300-interacting transactivator with Glu/Asp-rich C-terminal domain 2 Ratio (CITED2) from peripheral blood mononuclear cells in the collateral circulation of AIS. We classified the AIS patients into two groups (the good collateral group and the poor collateral group) by DWI-ASPECTS score. The western blot was applied to test the protein expression of vascular endothelial growth factor (VEGF) and CITED2. Then, we collected other clinical data. Binary logistic regression analysis between collateral circulation and clinical data was performed. Finally, Receiver operating characteristic (ROC) curve analysis was used to explore the predictive value of the CITED2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients were diagnosed with acute ischemic stroke in the neurology department of our hospital from November 2020 to November 2023.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* the first-time onset or previous stroke with mRS score ≤1, and the onset time less than 3 days without intravenous thrombolysis or endovascular therapy ;\n\n * age range of 18 to 80 years old;\n\n * patients with a clinical diagnosis of acute ischemic stroke; ④ NIHSS score ≥4; ⑤ patients volunteer to participate in this study and signed a written informed consent\n\nExclusion Criteria:\n\n* ①the patients with AIS combined with other diseases that may affect the CITED2 and VEGF expression, such as acute myocardial infarction, peripheral artery occlusion disease and congenital heart defect;\n\n * the patients exhibited serious heart, live or kidney diseases; ③disturbance of consciousness or mental illness; ④ patients with tumor; ⑤ pregnant and lactating patients.'}, 'identificationModule': {'nctId': 'NCT05345366', 'briefTitle': 'The Correlation Between CITED2 and Collateral Circulation in Acute Ischemic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Zhujiang Hospital'}, 'officialTitle': 'The Impact of CITED2 on Collateral Circulation and Early Neurological Functional Outcome for Ischemic Stroke by Critically Regulating HIF-1α-VEGF Pathway', 'orgStudyIdInfo': {'id': '2021LX0027-GC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'the good collateral group', 'interventionNames': ['Other: non-applicable']}, {'label': 'the poor collateral group', 'interventionNames': ['Other: non-applicable']}], 'interventions': [{'name': 'non-applicable', 'type': 'OTHER', 'description': 'non-applicable', 'armGroupLabels': ['the good collateral group', 'the poor collateral group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510260', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Zhujiang Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhujiang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}