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

NCT ID: NCT00725868

Last Updated: 2011-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2010-12-31

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%.

Conditions

Atherosclerosis; Percutaneous Coronary Intervention; Cardiovascular Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

1

Data private hospitals, angioplasty, sampling of blood

Group Type: OTHER

Data private hospitals, angioplasty, sampling of blood

Intervention Type: OTHER

• Data private hospitals : Age, sex, index of body mass, factors of cardiovascular risk, medical surgical histories, treatment before and after the angioplasty, the renal insufficiency
• coronary angioplasty
• Sampling of blood : Before the angioplasty, 6 hours after the angioplasty and 24 hours after the angioplasty. A numeration of the proparents circulants (hématopoietics, PEC) and a numeration of CEC are made

Interventions

Data private hospitals, angioplasty, sampling of blood

• Data private hospitals : Age, sex, index of body mass, factors of cardiovascular risk, medical surgical histories, treatment before and after the angioplasty, the renal insufficiency
• coronary angioplasty
• Sampling of blood : Before the angioplasty, 6 hours after the angioplasty and 24 hours after the angioplasty. A numeration of the proparents circulants (hématopoietics, PEC) and a numeration of CEC are made

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Assistance Publique Hopitaux De Marseille

Principal Investigators

Franck PAGANELLI, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique des Hopitaux de Marseille

Locations

Service de Cardiologie- Hopital Nord

Marseille, , France

Countries

France

Other Identifiers

2007-18

Identifier Type: -

Identifier Source: secondary_id

2007-A00533-50

Identifier Type: -

Identifier Source: org_study_id