Blood Endothelium Biomarkers to Predict Major Adverse Cardiovascular Events After Percutaneous Coronary Intervention

Not Applicable

Completed

• Conditions: Atherosclerosis; Percutaneous Coronary Intervention; Cardiovascular Diseases
• Interventions: Other: Data private hospitals, angioplasty, sampling of blood

• Registration Number: NCT00725868
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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%.

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-07-30
• Study First Submitted QC: 2008-07-30
• Study First Posted: 2008-07-31
• Primary Completion: 2010-08
• Study Completion: 2010-12
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-25
• Last Update Posted: 2011-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Data private hospitals, angioplasty, sampling of blood	Data private hospitals, angioplasty, sampling of blood

Primary Outcome Measures

Name	Time	Method
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.	36 months

Secondary Outcome Measures

Name	Time	Method
To determine the relation between these endothelial biomarkers and the other usual parameters forecast complications post-angioplasty	36 months

Trial Locations

Locations (1)

Service de Cardiologie- Hopital Nord; 🇫🇷 Marseille, France