TEDAC: Study of Prognostic Factors in Aortic Dissection Type B
Study Details
Study Description
Brief Summary
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.
The 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.
Expected 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- Correlation between the increase in the aortic diameter and the intensity of 18-FDG binding (Standard Uptake Value) at 1 year [1 year]
Secondary Outcome Measures
- Correlation between biomarkers of fibrosis and results of morphological and functional imaging [1 year]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients over 18 years old
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Chronic type B aortic dissection, without surgical treatment
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Medically treated patient
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Medical treatment since more than 1 month and less than 5 years
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Aortic dissection localization : below left subclavian artery and alow femoral artery
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Affiliation to a social security system
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Patient who have given informed consent
Exclusion Criteria:
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History of malignant pathology
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Aortic dissection since less than 1 month or more than 5 years
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Inflammatory or infectious disease of the aorta
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Uncontrolled infectious disease
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Iodine Allergy
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Severe renal insufficiency (cockcroft clearance <30 mL/min)
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Patient under guardianship or curators
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Any associated medical or psychological condition wich could compromise the patient's ability to participate in the study
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Inability to be submitted to the study follow-up for geographical, social or psychological reasons
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Current pregnancy or lack of effective contraception during their reproductive years
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Suckle
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Caen University Hospital | Caen | France |
Sponsors and Collaborators
- University Hospital, Caen
Investigators
- Principal Investigator: Ludovic BERGER, MD,PhD, Caen UH
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2013-A00209-36