Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2026-01-06 @ 10:45 AM
Study NCT ID:
NCT01860768
Status:
UNKNOWN
Last Update Posted:
2013-05-27
First Post:
2013-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Potential Biomarkers for Early Diagnosis of Acute Aortic Dissection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2015-09-29', 'releaseDate': '2015-09-01'}, {'resetDate': '2016-05-31', 'releaseDate': '2016-04-25'}], 'estimatedResultsFirstSubmitDate': '2015-09-01'}}, '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': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2014-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-05-24', 'studyFirstSubmitDate': '2013-05-04', 'studyFirstSubmitQcDate': '2013-05-22', 'lastUpdatePostDateStruct': {'date': '2013-05-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic accuracy(sensitivity and specificity of 400 participates for diagnosing acute aortic dissection) of serum biomarkers on patients with AAD.', 'timeFrame': '1 day (Emergency room without follow-up)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Acute aortic dissection', 'Serum biomarkers', 'Early diagnosis'], 'conditions': ['Aortic Dissection', 'Biomarkers and Early Diagnosis']}, 'descriptionModule': {'briefSummary': 'Acute aortic dissection (AAD) is an acute vascular lesions with high early misdiagnosis rate(31.8%), and mortality rate was 38%. In recent years, the incidence is rising and serious threat to human health. At present, the clinical diagnosis of AAD commonly used imaging methods, including chest X-ray, B ultrasound, CT, MRI and aortic angiography. Chest X-ray and two-dimensional ultrasound is limited in diagnosis of AAD, esophageal ultrasonography can display the intimal, identify the true and false lumen, but greater risk. CT, MRI and aortic angiography can be used as diagnosis method, but time-consuming, expensive and requires handling patients in emergency situations, should not be used as the preferred. Therefore, it is significance that biomarkers with high specificity and sensitivity for clinical fast diagnosis of AAD.\n\nParts small sample tests found that single serum α-smooth muscle actin (α-SMA), myosin heavy chain(MHC) and human soluble elastin fragments (sELAF) levels in patients with AAD were significantly higher than that of others (normal people, acute myocardial infarction patients). But because of the small study sample, limited control risk factors and incomplete comparison, their conclusions were questionable. In our previous studies also found that serum α-SMA, MHC and sELAF levels and the pathogenesis of AAD and prognosis are closely related. Therefore, on the basis, a prospective study is needed. We observe all the three biomarkers in enrolled patients with acute chest pain in emergency department, levels in healthy volunteers as the blank control. Then make definite diagnosis of the enrolled patients, and further observe the biomarkers dynamic change in AAD. Lastly, evaluate the early diagnostic value of combination serum α-SMA, MHC and sELAF level on patients with AAD.', 'detailedDescription': "This is a prospective clinical study designed to procure blood samples from patients who present to the Emergency Department with suspected AAD.\n\nSubjects enrolled in this study will sign and informed consent and have 3 blood samples drawn at different time points during their emergency department visit. In addition, data will be collected about the patient's health history, hospital procedures, and final diagnosis.\n\nBlood samples collected in this study will be sent to laboratory for long-term storage and analysis in the future for these blood markers as they become available. No genetic testing will be conducted on these samples."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Alll patients presenting to the Second Xiangya Hospital of Central South Unversity Emergency Department with acute chest pain.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chest pain without diagnosis confirmed\n* symptom occurred in 2 hours\n* ≥18 years old\n* Can complete the base information\n* Able and willing to give written consent\n\nExclusion Criteria:\n\n* known AAD\n* known causes of acute chest pain such as tumour and trauma\n* pregnant or lactating female\n* Associated chronic inflammatory diseases'}, 'identificationModule': {'nctId': 'NCT01860768', 'briefTitle': 'Potential Biomarkers for Early Diagnosis of Acute Aortic Dissection', 'organization': {'class': 'OTHER', 'fullName': 'Central South University'}, 'officialTitle': 'Potential Biomarkers for Early Diagnosis of Acute Aortic Dissection', 'orgStudyIdInfo': {'id': '2XY-ED-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'acute aortic dissectin patients', 'description': 'definite diagnosis by computed tomography arteriography (CTA).'}, {'label': 'acute chest pain patients', 'description': 'aortic dissection is exclude by aorta CTA'}]}, 'contactsLocationsModule': {'locations': [{'zip': '410011', 'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'PENG Wen, Master', 'role': 'CONTACT', 'email': 'suiyuehuakai@qq.com'}], 'facility': 'The Second Xiangya Hospital of Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'centralContacts': [{'name': 'CHAI Xiangping, MD', 'role': 'CONTACT', 'email': 'fenghuaxuepiao@qq.com', 'phone': '+86-13787204259'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central South University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'vice director of emergency department; vice director of hospital office', 'investigatorFullName': 'CHAI Xiangping', 'investigatorAffiliation': 'Central South University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2015-09-01', 'type': 'RELEASE'}, {'date': '2015-09-29', 'type': 'RESET'}, {'date': '2016-04-25', 'type': 'RELEASE'}, {'date': '2016-05-31', 'type': 'RESET'}], 'unpostedResponsibleParty': 'CHAI Xiangping, vice director of emergency department; vice director of hospital office, Second Xiangya Hospital of Central South University'}}}}