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

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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Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Restenosis Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitair Ziekenhuis Antwerpen

Edegem, Antwerpen, 2650, Belgium

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
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

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Registry information

Official study title

Blood Endothelium Progenitor Cells and Dendritic Cells as Novel Predictive Biomarkers of In-stent Restenosis After Percutaneous Coronary Intervention.

Important dates

Study start: 2007
Primary completion: 2020
Study completion: 2020
First posted: Jun 28, 2007
Registry last updated: Nov 4, 2022

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.

Published trials that share one or more normalized conditions with this study.

Completed