Study of Prognostic Factors in Aortic Dissection Type B

Type B Aortic Dissection Clinical Trial

— TEDAC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01984905
• Other study ID #: 2013-A00209-36
• Status: Recruiting
• Phase: N/A
• First received: October 25, 2013
• Last updated: November 8, 2013
• Start date: October 2013
• Est. completion date: December 2017

Study information

• Verified date: November 2013
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Type B Aortic Dissection

Locations

Country	Name	City	State
France	Caen University Hospital	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between the increase in the aortic diameter and the intensity of 18-FDG binding (Standard Uptake Value) at 1 year		1 year	No
Secondary	Correlation between biomarkers of fibrosis and results of morphological and functional imaging		1 year	No