Dissection of the Descending AortaDADINCT01648881
Imaging of Dissection of the Descending Aorta
An observational study of Dissection of the Descending Aorta, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Patients with dissection of the descending aorta will be followed up according to a precise timeline. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dissection of the Descending Aorta
- What is being tested?
- TEP-18FDG for every patient after aortic dissection
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 89 participants
- Where
- 1 siteFrance
- Study dates
- May 2011to Aug 2019
- 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 with dissection of the descending aorta
Who may be able to join
- 18 years
- Seen for dissection of the descending aorta
- Dissection of the descending aorta within the last three months
- Affiliation to social security
- Signed informed consent
Who cannot join
- intervention programmed in relation with dissection of the descending aorta
- Pregnant female
- Adults without legal capacity
Trial locations and contacts
1 site in 1 country.
France1 site
Pr Guillaume JONDEAU . Cardiologie. Hôpital Bichat
Paris, Île-de-France Region, 75018
About this study
Official title: Dissection of Aorta: Descending Part, Imaging
Patients with dissection of the descending aorta will be followed up according to a precise timeline.
Read the detailed description
NMR baseline A PET Scanner will be performed minimum 3 months post dissection 6 months and every year during three years after PET scanner : CT scanner and blood sample
- Conditions
- Dissection of the Descending Aorta
- Being tested
- TEP-18FDG for every patient after aortic dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEP-18FDG for every patient after aortic dissectionRadiation
Also called TEP-18FDG
Cover key details of the intervention. Must be sufficiently detailed to distinguish between arms of a study (e.g., comparison of different dosages of drug) and/or among similar interventions (e.g., comparison of multiple implantable cardiac defibrillators). For example, interventions involving drugs may include dosage form, dosage, frequency and duration.
Example: 50 mg/m2, IV (in the vein) on day 5 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2012 (estimated)
- Study startMay 2011
- Primary completionDec 2015
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dissection of the Descending AortaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume JONDEAU, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01648881
- Sponsor's protocol ID
- P 100505
- Other IDs
- 2011-A00238-33
- Acronym
- DADI
- Status last verified
- Sep 2019
- First submitted
- 20 Jul 2012
- Last updated
- 18 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dissection of Aorta: Descending Part, Imaging
- ClinicalTrials.gov ID
- NCT01648881
- Acronym / sponsor ID
- DADI / P 100505
- Conditions
- Dissection of the Descending Aorta
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- May 2011 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 24 Jul 2012 (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.
Patients with dissection of the descending aorta will be followed up according to a precise timeline.
Detailed description
NMR baseline A PET Scanner will be performed minimum 3 months post dissection 6 months and every year during three years after PET scanner : CT scanner and blood sample
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 with dissection of the descending aorta
Key inclusion criteria (5 listed)
- 18 years
- Seen for dissection of the descending aorta
- Dissection of the descending aorta within the last three months
- Affiliation to social security
- Signed informed consent
Key exclusion criteria (3 listed)
- intervention programmed in relation with dissection of the descending aorta
- Pregnant female
- Adults without legal capacity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TEP-18FDG for every patient after aortic dissectionAlso: TEP-18FDGCover key details of the intervention. Must be sufficiently detailed to distinguish between arms of a study (e.g., comparison of different dosages of drug) and/or among similar interventions (e.g., comparison of multiple implantable cardiac defibrillators). For example, interventions involving drugs may include dosage form, dosage, frequency and duration. Example: 50 mg/m2, IV (in the vein) on day 5 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops. | Radiation | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
- Individual participant dataSharing planned: Undecided
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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.
Guillaume JONDEAU principal investigator
Assistance Publique - Hôpitaux de Paris
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 Dissection of the Descending Aorta, run by Assistance Publique - Hôpitaux de Paris 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 18 Sep 2019. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 18 Sep 2019.