Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2026-02-28 @ 2:28 PM
Study NCT ID:
NCT01984905
Status:
TERMINATED
Last Update Posted:
2025-03-17
First Post:
2013-10-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Prognostic Factors in Aortic Dissection Type B
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000784', 'term': 'Aortic Dissection'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'insufficient patient recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2018-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-13', 'studyFirstSubmitDate': '2013-10-25', 'studyFirstSubmitQcDate': '2013-11-08', 'lastUpdatePostDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-11-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between the increase in the aortic diameter and the intensity of 18-FDG binding (Standard Uptake Value) at 1 year', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Correlation between biomarkers of fibrosis and results of morphological and functional imaging', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['18 FDG PET-scan', 'angioscan', 'aortic dissection'], 'conditions': ['Type B Aortic Dissection']}, 'descriptionModule': {'briefSummary': 'Clinical outcomes of chronic type B aortic dissections are unknown, especially in case of false lumen expansion and risk of rupture. Data of literature give us some indications about prognosis. The 1-year survival rate is about 80%, but we deplore the 25% rate of mortality at 3 years despite follow-up.The only known predictive factors are the initial diameter of more than 4 cm and the persistence of a false lumen patent.However, actual means of follow-up do not allow to predict severe complications. The aim of the sudy is to propose a diagnostic and preventive strategy for the follow-up of chronic type B aortic dissections treated medically.\n\nThe primary objective is then to evaluate the prognostic role of 18-FDG-PET Scan in such patients in order to predict the risk of aortic diameter growth of more than 5 mm in 1 year and/or of an aortic dissections extension at 1 year. The secondary objectives are to evaluate the link between fibrosis biomarkers MMP et TIMP) and the results of imaging results (evolution of diameter and extension and results of PET-Scan imaging) Methods: 100 patients to be included in 3 years History of chronic type B aortic dissection, treated medically, evolving since more than 1 month and less than 5 years.\n\nExpected results: Prognostic contribution of 18FDG-PET-Scan and biomarkers for the identification of patients at high risk of evolution. Elaboration of a decisional algorithm about follow-up modalities of chronic aortic dissections. Demonstration of a correlation between aortic diameter growth or aortic dissection extension and intensity of marker fixation with 18-FDG-PET-Scan.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients suffering from chronic type B aortic dissection (since more than 1 month and less than 5 years)and medically treated.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients over 18 years old\n* Chronic type B aortic dissection, without surgical treatment\n* Medically treated patient\n* Medical treatment since more than 1 month and less than 5 years\n* Aortic dissection localization : below left subclavian artery and alow femoral artery\n* Affiliation to a social security system\n* Patient who have given informed consent\n\nExclusion Criteria:\n\n* History of malignant pathology\n* Aortic dissection since less than 1 month or more than 5 years\n* Inflammatory or infectious disease of the aorta\n* Uncontrolled infectious disease\n* Iodine Allergy\n* Severe renal insufficiency (cockcroft clearance \\<30 mL/min)\n* Patient under guardianship or curators\n* Any associated medical or psychological condition wich could compromise the patient's ability to participate in the study\n* Inability to be submitted to the study follow-up for geographical, social or psychological reasons\n* Current pregnancy or lack of effective contraception during their reproductive years\n* Suckle"}, 'identificationModule': {'nctId': 'NCT01984905', 'acronym': 'TEDAC', 'briefTitle': 'Study of Prognostic Factors in Aortic Dissection Type B', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'Exploratory Study of Prognostic Factors in Aortic Dissection Type B: Role of Imaging (18F-FDG PET-Scan and Angioscan) and Biomarkers', 'orgStudyIdInfo': {'id': '2013-A00209-36'}}, 'contactsLocationsModule': {'locations': [{'city': 'Caen', 'country': 'France', 'facility': 'Caen University Hospital', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}], 'overallOfficials': [{'name': 'Ludovic BERGER, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Caen UH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}