Back to resultsPrognostic Value of Biomarkers Associated With Endothelial Progenitor Cells Mobilization in Acute Coronary Syndromes
Primary Purpose
Acute Coronary Syndromes
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood sample
Sponsored by
About this trial
This is an interventional other trial for Acute Coronary Syndromes
Eligibility Criteria
Inclusion Criteria:
- acute coronary syndrome (ST + < 12 hours and ST- high risk or intermediate risk ),which there is an indication of percutaneous coronary intervention.
Exclusion Criteria:
- Cancer
- Chronic inflammatory disease
- Infectious disease
- Erythrocyte <4 G/l
- Thrombopénia less than 100 000/mm3 ;
Sites / Locations
- assistance Publique Hopitaux de Marseille
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
study of PEC markers and chemokines/ chemokine recep
Arm Description
blood sample for dosage and study of PEC markers and chemokines/ chemokine receptors
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
determine the technical characteristics (sensitivity and specificity) and predictive value of the number of PEC
Full Information
NCT ID
NCT02117037
First Posted
April 15, 2014
Last Updated
August 30, 2018
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT02117037
Brief Title
Prognostic Value of Biomarkers Associated With Endothelial Progenitor Cells Mobilization in Acute Coronary Syndromes
Official Title
Prognostic Value of Biomarkers Associated With Endothelial Progenitor Cells Mobilization in Acute Coronary Syndromes
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
June 2014 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
No
5. Study Description
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,
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndromes
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
study of PEC markers and chemokines/ chemokine recep
Arm Type
Other
Arm Description
blood sample for dosage and study of PEC markers and chemokines/ chemokine receptors
Intervention Type
Other
Intervention Name(s)
blood sample
Primary Outcome Measure Information:
Title
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.
Time Frame
one year
Secondary Outcome Measure Information:
Title
determine the technical characteristics (sensitivity and specificity) and predictive value of the number of PEC
Time Frame
one day , one month , one year
Other Pre-specified Outcome Measures:
Title
determine the technical characteristics (sensitivity and specificity) and performance (technical and predictive) of chemokines / receptors expression in the occurrence of ECVM
Time Frame
one day, one month ,one year
Title
Determine the above performance in the subgroup of patients defined as incompletely revascularized (at least a residual stenosis < 70%)
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
acute coronary syndrome (ST + < 12 hours and ST- high risk or intermediate risk ),which there is an indication of percutaneous coronary intervention.
Exclusion Criteria:
Cancer
Chronic inflammatory disease
Infectious disease
Erythrocyte <4 G/l
Thrombopénia less than 100 000/mm3 ;
Facility Information:
Facility Name
assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13015
Country
France
12. IPD Sharing Statement
Learn more about this trial
Prognostic Value of Biomarkers Associated With Endothelial Progenitor Cells Mobilization in Acute Coronary Syndromes
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