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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02117037
Other study ID # 2014-04
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2014
Est. completion date August 2018

Study information

Verified date August 2018
Source Assistance Publique Hopitaux De Marseille
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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,


Recruitment information / eligibility

Status Completed
Enrollment 180
Est. completion date August 2018
Est. primary completion date August 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 ;

Study Design


Intervention

Other:
blood sample


Locations

Country Name City State
France assistance Publique Hopitaux de Marseille Marseille

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Other 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
Other Determine the above performance in the subgroup of patients defined as incompletely revascularized (at least a residual stenosis < 70%) one year
Primary 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 determine the technical characteristics (sensitivity and specificity) and predictive value of the number of PEC one day , one month , one year
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