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

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Completed

Conditions: Percutaneous Coronary Intervention; Cardiovascular Diseases; Atherosclerosis

Treatments: Other: Data private hospitals, angioplasty, sampling of blood

Study type: Interventional

Funder types: Other

Identifiers

NCT00725868

2007-18

2007-A00533-50

Details and patient eligibility

About

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.

Full 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%.

Enrollment: 170 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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170 participants in 1 patient group

1

Other group

Description:

Data private hospitals, angioplasty, sampling of blood

Treatment:

Other: Data private hospitals, angioplasty, sampling of blood