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Blood Endothelium Progenitor Cells and Dendritic Cells as Predictive Biomarkers of in-Stent Restenosis

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ClinicalTrials.gov Identifier: NCT00493597
Recruitment Status : Unknown
Verified October 2007 by University Hospital, Antwerp.
Recruitment status was:  Recruiting
First Posted : June 28, 2007
Last Update Posted : February 2, 2009
Sponsor:
Information provided by:
University Hospital, Antwerp

Brief 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.

Condition or disease
Atherosclerosis Restenosis

Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Blood Endothelium Progenitor Cells and Dendritic Cells as Novel Predictive Biomarkers of in-Stent Restenosis After Percutaneous Coronary Intervention.
Study Start Date : October 2007




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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Non-diabetic patients scheduled for PCI with a single bare metal stent in a significant de novo coronary lesion
Criteria

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00493597


Contacts
Contact: Steven E Haine, MD 0032.3.821.42.81 Steven.Haine@uza.be
Contact: Myriam Michiels, Nurse 0032.3.821.33.04 Myriam.Michiels@uza.be

Locations
Belgium
Universitair Ziekenhuis Antwerpen Recruiting
Edegem, Antwerpen, Belgium, 2650
Contact: Steven E Haine, MD    0032.3.821.42.81    Steven.Haine@uza.be   
Principal Investigator: Steven E Haine, MD         
Principal Investigator: Chris Vrints, MD, PhD         
Sub-Investigator: Johan M Bosmans, MD, PhD         
Sub-Investigator: Marc Claeys, MD, PhD         
Sub-Investigator: Hielko P Miljoen, MD         
Sponsors and Collaborators
University Hospital, Antwerp
Investigators
Principal Investigator: Steven E Haine, MD UZ Antwerpen

Responsible Party: Haine, Steven, MD, University Hospital of Antwerp
ClinicalTrials.gov Identifier: NCT00493597     History of Changes
Other Study ID Numbers: EC 7/5/36
First Posted: June 28, 2007    Key Record Dates
Last Update Posted: February 2, 2009
Last Verified: October 2007

Keywords provided by University Hospital, Antwerp:
Atherosclerosis
Restenosis
EPC
DC

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases