NCT02919709

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

September 27, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 29, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

July 18, 2018

Status Verified

July 1, 2018

Enrollment Period

5 years

First QC Date

September 27, 2016

Last Update Submit

July 17, 2018

Conditions

Thoracic or Abdominal Aortic Aneurysm With no Indication for Surgical Treatment

Outcome Measures

Primary Outcomes (5)

  • progenitor cells CD34+ blood levels

    At diagnosis of aneurysm

  • progenitor cells CD34+ blood levels

    6 month after disgnosis

  • progenitor cells CD34+ blood levels

    12 month after diagnosis

  • progenitor cells CD34+ blood levels

    18 month after diagnosis

  • progenitor cells CD34+ blood levels

    24 month after diagnosis

Study Arms (1)

thoracic or abdominal aortic aneurysm

EXPERIMENTAL
Biological: blood taking

Interventions

blood takingBIOLOGICAL
thoracic or abdominal aortic aneurysm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Besançon

Besançon, 25000, France

RECRUITING

Central Study Contacts

Andrea PERROTTI, MD

CONTACT

aperrotti@chu-besancon.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2016

First Posted

September 29, 2016

Study Start

November 1, 2013

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

July 18, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)