Study of Prognostic Factors in Aortic Dissection Type B

NCT01984905 | Terminated

• 1 other identifier: 2013-A00209-36
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Type B Aortic Dissection

Keywords

18 FDG PET-scan; angioscan; aortic dissection

Outcome Measures

Primary Outcomes (1)

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

  1 year

Secondary Outcomes (1)

• Correlation between biomarkers of fibrosis and results of morphological and functional imaging

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Caen University Hospital

Caen, France

Location

MeSH Terms

Conditions

Aortic Dissection

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases

Study Officials

• Ludovic BERGER, MD,PhD

  Caen UH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2013
• First Posted: November 15, 2013
• Study Start: October 25, 2013
• Primary Completion: May 15, 2018
• Study Completion: May 15, 2018
• Last Updated: March 17, 2025

Record last verified: 2025-03

Locations

FR (1)