Study of Prognostic Factors in Aortic Dissection Type B

Exploratory Study of Prognostic Factors in Aortic Dissection Type B: Role of Imaging (18F-FDG PET-Scan and Angioscan) and Biomarkers

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01984905

Acronym

TEDAC

Enrollment

100

Registered

2013-11-15

Start date

2013-10-25

Completion date

2018-05-15

Last updated

2025-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type B Aortic Dissection

Keywords

18 FDG PET-scan, angioscan, aortic dissection

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients over 18 years old * Chronic type B aortic dissection, without surgical treatment * Medically treated patient * Medical treatment since more than 1 month and less than 5 years * Aortic dissection localization : below left subclavian artery and alow femoral artery * Affiliation to a social security system * Patient who have given informed consent

Exclusion criteria

* History of malignant pathology * Aortic dissection since less than 1 month or more than 5 years * Inflammatory or infectious disease of the aorta * Uncontrolled infectious disease * Iodine Allergy * Severe renal insufficiency (cockcroft clearance \<30 mL/min) * Patient under guardianship or curators * Any associated medical or psychological condition wich could compromise the patient's ability to participate in the study * Inability to be submitted to the study follow-up for geographical, social or psychological reasons * Current pregnancy or lack of effective contraception during their reproductive years * Suckle

Design outcomes

Primary

Measure	Time frame
Correlation between the increase in the aortic diameter and the intensity of 18-FDG binding (Standard Uptake Value) at 1 year	1 year

Secondary

Measure	Time frame
Correlation between biomarkers of fibrosis and results of morphological and functional imaging	1 year

Countries

France

Outcome results