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

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Atherosclerosis; Percutaneous Coronary Intervention
• Intervention / Treatment: Other: Data private hospitals, angioplasty, sampling of blood

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 Type: Interventional
• Enrollment (Anticipated): 170
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13015
    • Service de Cardiologie- Hopital Nord

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

OTHER: 1; Data private hospitals, angioplasty, sampling of blood

Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille
• Investigators: Principal Investigator: Franck PAGANELLI, MD, Assistance Publique des Hôpitaux de Marseille

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (ACTUAL): August 1, 2010
• Study Completion (ACTUAL): December 1, 2010

Study Registration Dates

• First Submitted: July 30, 2008
• First Submitted That Met QC Criteria: July 30, 2008
• First Posted (ESTIMATE): July 31, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): August 26, 2011
• Last Update Submitted That Met QC Criteria: August 25, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: Major adverse
• Additional Relevant MeSH Terms: Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Cardiovascular Diseases; Atherosclerosis
• Other Study ID Numbers: 2007-A00533-50; 2007-18