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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
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

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

1

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

First Posted
July 30, 2008
Last Updated
August 25, 2011
Sponsor
Assistance Publique Hopitaux De Marseille
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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
No

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
1
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
No
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

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

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