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

Primary Purpose

Atherosclerosis, Percutaneous Coronary Intervention, Cardiovascular Diseases

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Data private hospitals, angioplasty, sampling of blood

About this trial

This is an interventional diagnostic trial for Atherosclerosis focused on measuring Major adverse

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Service de Cardiologie- Hopital Nord

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Arm Description

Data private hospitals, angioplasty, sampling of blood

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

To determine the relation between these endothelial biomarkers and the other usual parameters forecast complications post-angioplasty

Full Information

NCT ID

NCT00725868

First Posted

July 30, 2008

Last Updated

August 25, 2011

Sponsor

Assistance Publique Hopitaux De Marseille

1. Study Identification

Unique Protocol Identification Number

NCT00725868

Brief Title

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

2. Study Status

Record Verification Date

August 2011

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

August 2010 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee

5. Study Description

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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atherosclerosis, Percutaneous Coronary Intervention, Cardiovascular Diseases

Keywords

Major adverse

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Other

Arm Description

Data private hospitals, angioplasty, sampling of blood

Intervention Type

Other

Intervention Name(s)

Data private hospitals, angioplasty, sampling of blood

Intervention Description

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

Primary Outcome Measure Information:

Title

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.

Time Frame

36 months

Secondary Outcome Measure Information:

Title

To determine the relation between these endothelial biomarkers and the other usual parameters forecast complications post-angioplasty

Time Frame

36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Franck PAGANELLI, MD

Organizational Affiliation

Assistance Publique des Hopitaux de Marseille

Official's Role

Principal Investigator

Facility Information:

Facility Name

Service de Cardiologie- Hopital Nord

City

Marseille

ZIP/Postal Code

13015

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

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