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

July 17, 2018 updated by: Centre Hospitalier Universitaire de Besancon
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: thoracic or abdominal aortic aneurysm
Biological: blood taking

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
progenitor cells CD34+ blood levels
Time Frame: At diagnosis of aneurysm
At diagnosis of aneurysm
progenitor cells CD34+ blood levels
Time Frame: 6 month after disgnosis
6 month after disgnosis
progenitor cells CD34+ blood levels
Time Frame: 12 month after diagnosis
12 month after diagnosis
progenitor cells CD34+ blood levels
Time Frame: 18 month after diagnosis
18 month after diagnosis
progenitor cells CD34+ blood levels
Time Frame: 24 month after diagnosis
24 month after diagnosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Anticipated)

November 1, 2018

Study Completion (Anticipated)

November 1, 2018

Study Registration Dates

First Submitted

September 27, 2016

First Submitted That Met QC Criteria

September 27, 2016

First Posted (Estimate)

September 29, 2016

Study Record Updates

Last Update Posted (Actual)

July 18, 2018

Last Update Submitted That Met QC Criteria

July 17, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P/2013/186

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe