NCT02117037

Brief Summary

This prospective study aimed to validate a new prognostic approach of endothelial progenitor cells associated biomarkers in patients with acute coronary syndromes . Recruitment is made prospectively by two centers of Inter -region South Mediterranean,

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

April 15, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 17, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

May 8, 2026

Status Verified

August 1, 2018

Enrollment Period

3.2 years

First QC Date

April 15, 2014

Last Update Submit

May 4, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • evaluate the value of circulating endothelial progenitor cells quantification in the initial phase of ACS in predicting the occurrence of a major cardiovascular event (ECVM ) at 1 year.

    one year

Secondary Outcomes (1)

  • determine the technical characteristics (sensitivity and specificity) and predictive value of the number of PEC

    one day , one month , one year

Other Outcomes (2)

  • determine the technical characteristics (sensitivity and specificity) and performance (technical and predictive) of chemokines / receptors expression in the occurrence of ECVM

    one day, one month ,one year

  • Determine the above performance in the subgroup of patients defined as incompletely revascularized (at least a residual stenosis < 70%)

    one year

Study Arms (1)

study of PEC markers and chemokines/ chemokine recep

OTHER

blood sample for dosage and study of PEC markers and chemokines/ chemokine receptors

Other: blood sample

Interventions

study of PEC markers and chemokines/ chemokine recep

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • acute coronary syndrome (ST + \< 12 hours and ST- high risk or intermediate risk ),which there is an indication of percutaneous coronary intervention.

You may not qualify if:

  • Cancer
  • Chronic inflammatory disease
  • Infectious disease
  • Erythrocyte \<4 G/l
  • Thrombopénia less than 100 000/mm3 ;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

assistance Publique Hopitaux de Marseille

Marseille, 13015, France

Location

Related Publications (1)

  • Buelens C, De Groote D, Goldman M, Willems F. Differential effects of interleukin-10 on the production of interleukin-12 and interleukin-8 by human dendritic cells generated from peripheral blood. Transplant Proc. 1996 Dec;28(6):3255-6. No abstract available.

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

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

Study Record Dates

First Submitted

April 15, 2014

First Posted

April 17, 2014

Study Start

June 1, 2014

Primary Completion

August 1, 2017

Study Completion

August 1, 2018

Last Updated

May 8, 2026

Record last verified: 2018-08

Locations