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NCT00493597 Clinical Trial

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

Atherosclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00493597
Other study ID # EC 7/5/36
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2007
Est. completion date October 26, 2020

Study information
Verified date November 2022
Source University Hospital, Antwerp
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 124
Est. completion date October 26, 2020
Est. primary completion date October 26, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Belgium Universitair Ziekenhuis Antwerpen Edegem Antwerpen

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

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