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Follow up of Patients With Aortic Aneurysm by Dosage of Circulant Endothelial Progenitor Cells (ANOPEC 3)

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ClinicalTrials.gov Identifier: NCT02919709
Recruitment Status : Recruiting
First Posted : September 29, 2016
Last Update Posted : September 29, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Brief Summary:
The study aims to investigate the existence of a reliable correlation between the progression of aortic diameters and blood levels of circulant endothelial progenitor cells CD34+ in patients with not surgical aortic aneurysms.

Condition or disease Intervention/treatment Phase
Thoracic or Abdominal Aortic Aneurysm With no Indication for Surgical Treatment Biological: blood taking Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Follow up of Patients With Aortic Aneurysm by Dosage of Circulant Endothelial Progenitor Cells
Study Start Date : November 2013
Estimated Primary Completion Date : November 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: thoracic or abdominal aortic aneurysm Biological: blood taking



Primary Outcome Measures :
  1. progenitor cells CD34+ blood levels [ Time Frame: At diagnosis of aneurysm ]
  2. progenitor cells CD34+ blood levels [ Time Frame: 6 month after disgnosis ]
  3. progenitor cells CD34+ blood levels [ Time Frame: 12 month after diagnosis ]
  4. progenitor cells CD34+ blood levels [ Time Frame: 18 month after diagnosis ]
  5. progenitor cells CD34+ blood levels [ Time Frame: 24 month after diagnosis ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients aged 18 or more.
  2. Patients diagnosed with a thoracic or abdominal aortic aneurysm with no indication for surgical treatment (diameters > 30 mm but < 50 mm).
  3. Patients accepting to sign a specific informed consent.

Exclusion Criteria:

  1. Unstable coronary artery disease.
  2. Congenital heart disease.
  3. Any evolving infectious syndrome or viral infection (HIV, HBV or HCV).
  4. Any chronic inflammatory or autoimmune disease.
  5. Prior administration of G-CSF; EPO; GM-CSF.
  6. Liver failure.
  7. Prior oncologic disease or ongoing cancer with a life expectancy < 1 year.
  8. Dementia.
  9. Pregnancy.
  10. Patients aged < 18.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02919709


Contacts
Contact: Andrea PERROTTI, MD aperrotti@chu-besancon.fr

Locations
France
CHRU de Besançon Recruiting
Besançon, France, 25000
Contact: Andréa PERROTTI, MD       aperrotti@chu-besancon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon

Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02919709     History of Changes
Other Study ID Numbers: P/2013/186
First Posted: September 29, 2016    Key Record Dates
Last Update Posted: September 29, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases