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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00725868
First Posted: July 31, 2008
Last Update Posted: August 26, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Assistance Publique Hopitaux De Marseille
  Purpose
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.

Condition Intervention
Atherosclerosis Percutaneous Coronary Intervention Cardiovascular Diseases Other: Data private hospitals, angioplasty, sampling of blood

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Blood Endothelium Biomarkers to Predict Major Adverse Cardiovascular Events After Percutaneous Coronary Intervention.

Resource links provided by NLM:


Further study details as provided by Assistance Publique Hopitaux De Marseille:

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. [ Time Frame: 36 months ]

Secondary Outcome Measures:
  • To determine the relation between these endothelial biomarkers and the other usual parameters forecast complications post-angioplasty [ Time Frame: 36 months ]

Estimated Enrollment: 170
Study Start Date: September 2007
Study Completion Date: December 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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%.
  Eligibility

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00725868


Locations
France
Service de Cardiologie- Hopital Nord
Marseille, France, 13015
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Principal Investigator: Franck PAGANELLI, MD Assistance Publique des Hopitaux de Marseille
  More Information

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT00725868     History of Changes
Other Study ID Numbers: 2007-A00533-50
2007-18
First Submitted: July 30, 2008
First Posted: July 31, 2008
Last Update Posted: August 26, 2011
Last Verified: August 2011

Keywords provided by Assistance Publique Hopitaux De Marseille:
Major adverse

Additional relevant MeSH terms:
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases