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OpenTrials
Completed

NCT Number: NCT00725868

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de Cardiologie- Hopital Nord

Marseille, 13015, France

About this study

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%.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Data private hospitals, angioplasty, sampling of blood

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

Primary outcomes

  1. 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 outcomes

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

    Time frame: 36 months

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jul 31, 2008
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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