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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00725868
• Other study ID #: 2007-A00533-50
• Secondary ID: 2007-18
• Status: Completed
• Phase: N/A
• First received: July 30, 2008
• Last updated: August 25, 2011
• Start date: September 2007
• Est. completion date: December 2010

Study information

• Verified date: August 2011
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: December 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Atherosclerosis
• Cardiovascular Diseases
• Percutaneous Coronary Intervention

Intervention

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

Locations

Country	Name	City	State
France	Service de Cardiologie- Hopital Nord	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To determine the relation between these endothelial biomarkers and the other usual parameters forecast complications post-angioplasty		36 months	No