Type B Aortic DissectionTEDACNCT01984905
Study of Prognostic Factors in Aortic Dissection Type B
An observational study of Type B Aortic Dissection, run by University Hospital, Caen at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type B Aortic Dissection
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 25 Oct 2013to 15 May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering from chronic type B aortic dissection (since more than 1 month and less than 5 years)and medically treated.
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Type B Aortic Dissection
- Keywords
- 18 FDG PET-scan, angioscan, aortic dissection
- Medical subject headings
- Aortic Dissection
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the increase in the aortic diameter and the intensity of 18-FDG binding (Standard Uptake Value) at 1 year
Measured: 1 year
Secondary outcomes (1)
Correlation between biomarkers of fibrosis and results of morphological and functional imaging
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2013 (estimated)
- Study start25 Oct 2013
- Primary completion15 May 2018
- Study completion15 May 2018
Why it stopped: insufficient patient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type B Aortic DissectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ludovic BERGER, MD,PhD, Principal investigator, Caen UH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01984905
- Sponsor's protocol ID
- 2013-A00209-36
- Acronym
- TEDAC
- Status last verified
- Mar 2025
- First submitted
- 25 Oct 2013
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of Prognostic Factors in Aortic Dissection Type B: Role of Imaging (18F-FDG PET-Scan and Angioscan) and Biomarkers
- ClinicalTrials.gov ID
- NCT01984905
- Acronym / sponsor ID
- TEDAC / 2013-A00209-36
- Conditions
- Type B Aortic Dissection
- Keywords
- 18 FDG PET-scan, angioscan, aortic dissection
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: insufficient patient recruitment
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 25 Oct 2013 (actual)
- Primary completion
- 15 May 2018 (actual)
- Study completion
- 15 May 2018 (actual)
- First posted
- 15 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from chronic type B aortic dissection (since more than 1 month and less than 5 years)and medically treated.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between the increase in the aortic diameter and the intensity of 18-FDG binding (Standard Uptake Value) at 1 year
Time frame: 1 year
1 secondary outcome
Correlation between biomarkers of fibrosis and results of morphological and functional imaging
Time frame: 1 year
Results and safety
The study was stopped early (reason given: insufficient patient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ludovic BERGER, MD,PhD principal investigator
Caen UH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type B Aortic Dissection, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: insufficient patient recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between the increase in the aortic diameter and the intensity of 18-FDG binding (Standard Uptake Value) at 1 year (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025; AzTrials last refreshed its copy on 1 Nov 2026.