Blood Endothelium Progenitor Cells and Dendritic Cells as Predictive Biomarkers of In-stent Restenosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

124 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-10-31

Study Completion Date

2020-10-26

Brief Summary

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clinically relevant in stent restenosis occurs in 5-10% of the non-diabetic patients treated with a coronary bare metal stent. Recent research has identified endothelial progenitor cells as well as dendritic cells as components of neointima. Numerical and functional evaluation of endothelial progenitor and dendritic cells at the time of coronary stent implantation is assessed and the relation with clinical and/or angiographic restenosis at 6 months post-stent implantation is evaluated.

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Detailed Description

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Conditions

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Atherosclerosis Restenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Age\>18 years old
* Scheduled for PCI
* Candidate for CABG if necessary
* Clinical evidence of ischemic heart disease and/or abnormal functional study
* New native coronary artery lesion \>50%-\<100% stenosis
* Lesion length\<30 mm, treatment with a single bare metal stent planned
* Reference diameter 2.5-3.5 mm
* 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 myocardial infarction (ST-elevation, Q-wave evolution or CK-MB \>2x upper limit of normal)in the past month
* Contra-indication to PCI
* Diabetes mellitus
* Planned drug eluting stent implantation
* Total occlusion (TIMI 0 or 1)
* Ostial localisation (\<3.0 mm of the coronary ostium) of the lesion
* Bifurcational lesion with side branch \>2.0 mm or side branch which will be recanalised at occlusion due to PCI
* Lesion in arterial or venous bypass or anastomosis with coronary
* Angiographic contra-indication to IVUS
* Severe renal insufficiency (creatinine clearance \<30 mL/')
* Severe hepatic insufficiency
* Systemic inflammatory pathology of any kind
* Uncorrected hyperthyreosis
* Hematologic or other malignancy, prior radio- or chemotherapy
* Severe peripheral artery disease (accesproblem via groin)
* Use of corticosteroïds or immune suppression therapy
* Contrastallergy
* Life expectancy \<1 year
* Participation in other clinical study which has not ended yet

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No