- Aortic AneurysmANOPEC3NCT01918982
Circulating Endothelial Progenitor Cells and Aortic Aneurysm
An observational study of - Aortic Aneurysm, run by Hopital Jean Minjoz.
Trial summary
We aimed to see if aortic aneurysms could be followed-up by circulating endothelial progenitor cells CD34+144+CD14- and CD34+VEGF-R2+CD14- blood level. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- - Aortic Aneurysm
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to May 2016
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with aortic aneurysm
Who may be able to join
- Aortic aneurysm size >30mm and > 50mm
Who cannot join
- Infectious disease
- Inflammatory disease
- Liver insuffisency
- Cancer evolutive
- Pregnant women
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Interest of Circulating Endothelial Progenitor Cells CD34+144+CD14- and CD34+VEGF-R2+CD14- in the Follow-up of Aortic Aneurysm
We aimed to see if aortic aneurysms could be followed-up by circulating endothelial progenitor cells CD34+144+CD14- and CD34+VEGF-R2+CD14- blood level.
Read the detailed description
Circulating endothelial progenitor cells CD34+144+CD14- and CD34+VEGF-R2+CD14- have been shown to be inversely correlated to aortic aneurysm size. We aimed to see if aortic aneurysms could be followed-up by circulating endothelial progenitor cells CD34+144+CD14- and CD34+VEGF-R2+CD14- blood level. 40 patients followed for known aortic aneurysm >30mm and <50mm will be followed up every 6 months during 2 years. Each 6 months they will have a consultation by their physiologist with an echo or a CT-scan. At the same time, a 10ML blood sample will be taken to assess the circulating endothelial progenitor cells CD34+144+CD14- and CD34+VEGF-R2+CD14- blood level.
- Conditions
- - Aortic Aneurysm
- Keywords
- Aortic aneurysm, circulating endothelial progenitor cells
- Medical subject headings
- Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Aortic aneurysm | Patients with aortic aneurysm >30mm and < 50mm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circulating endothelial progenitor cells CD34+144+CD14- and CD34+VEGF-R2+CD14- blood concentration
Patients are followed for 2 years
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2013 (estimated)
- Study startOct 2013
- Primary completionFeb 2016 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for - Aortic AneurysmStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hopital Jean Minjoz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Sidney Chocron, Hopital Jean Minjoz
- Investigators
- Sidney Chocron, MD, PhD, Principal investigator, Université de Franche-comté. FranceAndrea Perrotti, MD, Principal investigator, Université de Franche-Comté. FranceSimon Rinckenbach, MD, PhD, Principal investigator, Université de Franche-Comté. FranceSiamak Davani, MD, PhD, Principal investigator, Université de Franche-Comté. France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01918982
- Sponsor's protocol ID
- 147/362
- Acronym
- ANOPEC3
- Status last verified
- Aug 2013
- First submitted
- 6 Aug 2013
- Last updated
- 8 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Parietti E, Pallandre JR, Deschaseaux F, Aupecle B, Durst C, Kantelip JP, Chocron S, Davani S. Presence of circulating endothelial progenitor cells and levels of stromal-derived factor-1alpha are associated with ascending aorta aneurysm size. Eur J Cardiothorac Surg. 2011 Jul;40(1):e6-12. doi: 10.1016/j.ejcts.2011.02.065. Epub 2011 Apr 9.
PubMed 21481600
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Circulating Endothelial Progenitor Cells CD34+144+CD14- and CD34+VEGF-R2+CD14- in the Follow-up of Aortic Aneurysm
- ClinicalTrials.gov ID
- NCT01918982
- Acronym / sponsor ID
- ANOPEC3 / 147/362
- Conditions
- - Aortic Aneurysm
- Keywords
- Aortic aneurysm, circulating endothelial progenitor cells
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hopital Jean MinjozUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Feb 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 8 Aug 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.
We aimed to see if aortic aneurysms could be followed-up by circulating endothelial progenitor cells CD34+144+CD14- and CD34+VEGF-R2+CD14- blood level.
Detailed description
Circulating endothelial progenitor cells CD34+144+CD14- and CD34+VEGF-R2+CD14- have been shown to be inversely correlated to aortic aneurysm size. We aimed to see if aortic aneurysms could be followed-up by circulating endothelial progenitor cells CD34+144+CD14- and CD34+VEGF-R2+CD14- blood level. 40 patients followed for known aortic aneurysm >30mm and <50mm will be followed up every 6 months during 2 years. Each 6 months they will have a consultation by their physiologist with an echo or a CT-scan. At the same time, a 10ML blood sample will be taken to assess the circulating endothelial progenitor cells CD34+144+CD14- and CD34+VEGF-R2+CD14- blood level.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aortic aneurysm | – | –Patients with aortic aneurysm >30mm and < 50mm |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with aortic aneurysm
Key inclusion criteria (1 listed)
- Aortic aneurysm size >30mm and > 50mm
Key exclusion criteria (5 listed)
- Infectious disease
- Inflammatory disease
- Liver insuffisency
- Cancer evolutive
- Pregnant women
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
Circulating endothelial progenitor cells CD34+144+CD14- and CD34+VEGF-R2+CD14- blood concentration
Time frame: 2 years
Patients are followed for 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2013.
- Background: PubMed 21481600Parietti E, Pallandre JR, Deschaseaux F, Aupecle B, Durst C, Kantelip JP, Chocron S, Davani S. Presence of circulating endothelial progenitor cells and levels of stromal-derived factor-1alpha are associated with ascending aorta aneurysm size. Eur J Cardiothorac Surg. 2011 Jul;40(1):e6-12. doi: 10.1016/j.ejcts.2011.02.065. Epub 2011 Apr 9.
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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.
Sidney Chocron, MD, PhD principal investigator
Université de Franche-comté. France
Andrea Perrotti, MD principal investigator
Université de Franche-Comté. France
Simon Rinckenbach, MD, PhD principal investigator
Université de Franche-Comté. France
Questions about this trial
What is this clinical trial studying?
An observational study of - Aortic Aneurysm, run by Hopital Jean Minjoz.
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 8 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sidney Chocron (+33381533121, sidney.chocron@univ-fcomte.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circulating endothelial progenitor cells CD34+144+CD14- and CD34+VEGF-R2+CD14- blood concentration (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01918982, which also lists 1 linked publication.
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 8 Aug 2013.