NCT01038700

Brief Summary

This part of the project aims to describe changes in markers of vascular competence (Endothelial Microparticles Platelet (EMP), Circulating endothelial cells (CEC) and Circulating endothelial progenitors (EPC)) at different ages of lifespan both in physiological state and in response to hypoxia-induced vascular stress.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2008

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 24, 2009

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

October 1, 2015

Status Verified

September 1, 2015

Enrollment Period

8 months

First QC Date

December 22, 2009

Last Update Submit

September 30, 2015

Conditions

Keywords

Circulating endothelial compartmentmicroparticlesendothelial progenitors cellscirculating endothelial cellstranscriptomeagingHealthy volunteers

Outcome Measures

Primary Outcomes (1)

  • Analyse of CEC, EMP and EPC at different ages of lifespan both in physiological state and in response to an hypoxia- induced vascular stress

    3 days

Secondary Outcomes (1)

  • Transcriptome analysis on EPC isolated from cord blood and peripheral blood from young and old adults

    end

Eligibility Criteria

Age10 Years - 90 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

healthy volunteers

You may qualify if:

  • Healthy volunteers of 20-30 and 60-70 years old
  • Non smokers male
  • Biological test in normal values : lipids, glucose, TGO, TGT, alkaline phosphatases, gamma-GT, bilirubin, creatinine, ionogram, Ca++, albumin, proteins, WBC, platelets count, coagulation tests (APTT, PT, Fibrinogen).
  • Negative HIV1 and 2, HBV (Hbs antigen) and HCV serology.
  • Normal ECG 12 derivations, arterial pressure and cardiac frequency.

You may not qualify if:

  • Evaluative disease in the past 10 days
  • Hemorrhagic disorders
  • Treatments with antiplatelets agents, oral or injectable anticoagulant
  • Statins, glitazones, EPO, G-CSF
  • Frequent faintness
  • Blood donation in the 3 months preceding the study
  • Refusal or linguistic or psychic incapacity to sign the enlightened consent
  • Biological parameters apart from the usual values of the healthy subject (Hb\<10 g/dL, TGO/TGT \> 2 times higher limit of normal values)
  • Prone not being able to subject to the constraints protocol (for example, not cooperating, incompetent to go to the visits of follow-up and probably incompetent to finish the study).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hegp- Cic

Paris, France

Location

Related Publications (2)

  • HoWangYin KY, Loinard C, Bakker W, Guerin CL, Vilar J, d'Audigier C, Mauge L, Bruneval P, Emmerich J, Levy BI, Pouyssegur J, Smadja DM, Silvestre JS. HIF-prolyl hydroxylase 2 inhibition enhances the efficiency of mesenchymal stem cell-based therapies for the treatment of critical limb ischemia. Stem Cells. 2014 Jan;32(1):231-43. doi: 10.1002/stem.1540.

  • Evrard SM, d'Audigier C, Mauge L, Israel-Biet D, Guerin CL, Bieche I, Kovacic JC, Fischer AM, Gaussem P, Smadja DM. The profibrotic cytokine transforming growth factor-beta1 increases endothelial progenitor cell angiogenic properties. J Thromb Haemost. 2012 Apr;10(4):670-9. doi: 10.1111/j.1538-7836.2012.04644.x.

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood

Study Officials

  • David SMADJA, PH

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 22, 2009

First Posted

December 24, 2009

Study Start

December 1, 2008

Primary Completion

August 1, 2009

Study Completion

September 1, 2010

Last Updated

October 1, 2015

Record last verified: 2015-09

Locations