Study of Prognostic Factors in Aortic Dissection Type B (TEDAC)

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

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.

Study Overview

• Status: Unknown
• Conditions: Type B Aortic Dissection

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• France
  • Caen, France
    • Recruiting
    • CAEN University Hospital
    • Contact: Ludovic Berger, MD; Email: berger-l@chu-caen.fr
    • Principal Investigator: Ludovic Berger, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients suffering from chronic type B aortic dissection (since more than 1 month and less than 5 years)and medically treated.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Investigators: Principal Investigator: Ludovic BERGER, MD,PhD, Caen UH

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: October 25, 2013
• First Submitted That Met QC Criteria: November 8, 2013
• First Posted (Estimate): November 15, 2013

Study Record Updates

• Last Update Posted (Estimate): November 15, 2013
• Last Update Submitted That Met QC Criteria: November 8, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: aortic dissection; 18 FDG PET-scan; angioscan
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aneurysm, Dissecting
• Other Study ID Numbers: 2013-A00209-36