Clinical trial NCT00725868: Blood Endothelium Biomarkers to Predict Major Adverse Cardiovascular Events After Percutaneous Coronary Intervention
Official title: Blood Endothelium Biomarkers to Predict Major Adverse Cardiovascular Events After Percutaneous Coronary Intervention.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atherosclerosis
Percutaneous Coronary Intervention
Cardiovascular Diseases
Keywords: Major adverse
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2008-07-31
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In stent restenosis and myocardial infarction are have been linked the balance between injury and healing of the endothelium These processes can be measured respectively using the number of circulating endothelial cells and endothelial progenitor cells. We therefore aimed to evaluate the relationship between the balance of injury and healing of the endothelium at the time of PCI and major adverse cardiovascular events including death, myocardial infarction and target lesion revascularization at 6 and 12 months follow-up.

Detailed description: Following percutaneous coronary intervention with bare metal stents, the rate of major adverse cardiovascular events including death, myocardial infarction and target lesion revascularization is high ranging between 20 and 25%.

Eligibility criteria: Inclusion Criteria:

* Age\>18 years old
* Scheduled for PCI
* Clinical evidence of ischemic heart disease and/or abnormal functional study
* New coronary artery lesion \>50%
* treatment with bare metal stent planned
* Informed consent explained, red, understood and signed by the patient

Exclusion Criteria:

* Pregnancy, birth or lactation period \<6 months ago
* Women of childbearing age who do not intend to use accepted anticonceptive measures or who wish to get pregnant
* Left ventricular ejection fraction \<30%
* Acute coronary syndrome (ST-elevation or not) in the past month
* Planned drug eluting stent implantation
* Lesion in arterial or venous bypass or anastomosis with coronary
* Severe renal insufficiency (creatinine clearance \<30 mL/')
* Severe hepatic insufficiency
* Systemic inflammatory pathology of any kind
* Hematologic or other malignancy, prior radio- or chemotherapy
* Use of corticosteroïds or immune suppression therapy
* Contrast allergy
* Life expectancy \<1 year
* Participation in other clinical study which has not ended yet

Primary outcomes:
measure: The main objective of this study is to estimate if the measure of CEC and PEC possesses a meaning forecast towards the arisen of complications post procedure.
timeFrame: 36 months
Secondary outcomes:
measure: To determine the relation between these endothelial biomarkers and the other usual parameters forecast complications post-angioplasty
timeFrame: 36 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Service de Cardiologie- Hopital Nord
Study officials:
affiliation: Assistance Publique des Hopitaux de Marseille
name: Franck PAGANELLI, MD
role: PRINCIPAL_INVESTIGATOR
References: