Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2026-02-20 @ 6:46 PM
Study NCT ID:
NCT02816892
Status:
UNKNOWN
Last Update Posted:
2016-06-29
First Post:
2016-04-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Significance of Serum Tenascin C in Patients With Acute Aortic Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000784', 'term': 'Aortic Dissection'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D000094665', 'term': 'Dissection, Blood Vessel'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000094683', 'term': 'Acute Aortic Syndrome'}, {'id': 'D001018', 'term': 'Aortic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-06-25', 'studyFirstSubmitDate': '2016-04-25', 'studyFirstSubmitQcDate': '2016-06-25', 'lastUpdatePostDateStruct': {'date': '2016-06-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The level of serum tenascin-C', 'timeFrame': 'lesser than 48hours', 'description': 'serum tenascin-C in ng/ml was measured by elasia'}], 'secondaryOutcomes': [{'measure': 'Characteristics of enrolled subjects', 'timeFrame': 'lesser than 48hours', 'description': 'age in years,sex,IBM in kg/m\\^2 and associated history was collected'}, {'measure': 'The level of D-D，C-reactive protein，elastic protein fragment', 'timeFrame': 'lesser than 48hours', 'description': 'The level of D-D in ng/ml，C-reactive proteinin ng/ml，elastic protein fragmentin ng/ml was measured by elasia'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['aortic dissection', 'biomarkers', 'diagnosis'], 'conditions': ['Aortic Dissection']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate Serum Tenascin C levels in patients with acute symptoms relating to a known or newly diagnosed aortic aneurysm in emergency department and reveals the possible role of Tenascin C in the development of the disease.', 'detailedDescription': 'Patients with acute and chronic aortic disease /survivors and non-survivors were compared. Further subgroup analysis on the characteristics of the aneurysm and patients were performed. The aneurysms (ruptured and dissected) were divided according to the style of the Stanford classification,according to the location of the pathology in aneurysms of the ascending thoracic aorta .the descending thoracic aorta, or the abdominal aorta.The subgroup were divided according to the extent of propagation of the disease (rupture,covered rupture, acute dissection, chronic dissection and ectasia). Rupture was defined by direct visualisation of the discontinuity of the aortic wall by computed tomography, sonography, intraoperative findings or at autopsy with detection of blood in the pleural, pericardial or abdominal cavity. Covert rupture was defined as an intramural haematoma without detection of free blood in the body cavities. Acute dissection was defined when blood separating the layers of the aortic media was newly diagnosed. Chronic dissection was defined as the absence of any visible propagation of a known dissection compared to preexisting examinations. Ectatic aneurysm was defined as a permanent localised dilatation of the aorta with a diameter of at least 50% greater than normal. Documentation of the surgical interventions and autopsy reports was used to confirm the diagnosis. In all patients the investigators collected the history, age of the patients, duration of pain, blood pressure at admission and laboratory parameters (haematocrit, creatinine) and Tenascin C Serum levels after admission to our emergency department immediately. The patients were followed up until hospital discharge and the outcome (survived/died) was recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients who were suspected acute aortic disease in emergency department of the second xiangya hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults\n* sudden severe thoracic or abdominal pain\n\nExclusion Criteria:\n\n* lesser than 18 years\n* pregnant women\n* trauma\n* tumour'}, 'identificationModule': {'nctId': 'NCT02816892', 'briefTitle': 'Significance of Serum Tenascin C in Patients With Acute Aortic Disease', 'organization': {'class': 'OTHER', 'fullName': 'Central South University'}, 'officialTitle': 'Significance of Serum Tenascin C in Patients With Acute Aortic Disease', 'orgStudyIdInfo': {'id': '2XY-ED-002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Rupture group', 'description': 'Rupture was defined by direct visualisation of the discontinuity of the aortic wall by computed tomography, sonography, intraoperative findings or at autopsy with detection of blood in the pleural, pericardial or abdominal cavity.'}, {'label': 'Covert rupture group', 'description': 'Covert rupture was defined as an intramural haematoma without detection of free blood in the body cavities.'}, {'label': 'Acute dissection group', 'description': 'Acute dissection was defined when blood separating the layers of the aortic media was newly diagnosed.'}, {'label': 'Chronic dissection group', 'description': 'Chronic dissection was defined as the absence of any visible propagation of a known dissection compared to preexisting examinations.'}, {'label': 'Ectatic aneurysm group', 'description': 'Ectatic aneurysm was defined as a permanent localised dilatation of the aorta with a diameter of at least 50% greater than normal'}]}, 'contactsLocationsModule': {'locations': [{'zip': '410011', 'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Tao Guo, M.D.', 'role': 'CONTACT', 'email': '447921730@qq.com'}], 'facility': 'The Second Xiangya Hospital of Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'centralContacts': [{'name': 'Xiangping Chai, M.D.', 'role': 'CONTACT', 'email': 'laochaicn@aliyun.com', 'phone': '+86-13787204259'}], 'overallOfficials': [{'name': 'Xiangping Chai, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Second Xiangya Hospital of Central South University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central South University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice Director of emergency department，director of hospital office', 'investigatorFullName': 'CHAI Xiangping', 'investigatorAffiliation': 'Central South University'}}}}