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CompletedNCT00493597Updated Nov 4, 2022

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

An observational study in Atherosclerosis and Restenosis, sponsored by University Hospital, Antwerp. Completed at 1 site in Belgium. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2022-11-04.

Sponsored by University Hospital, Antwerp · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
124
Ages
18 Years to 90 Years
Sex
All
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Study 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.

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Conditions studied

  • Atherosclerosis
  • Restenosis

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Keywords

  • Atherosclerosis
  • Restenosis
  • EPC
  • DC
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In context

Atherosclerosis

1,567 studies on the registry are indexed under Atherosclerosis; 264 are open to participants now.

This study's enrollment of 124 is below the median of 223 across 571 observational studies indexed under Atherosclerosis.

Browse Atherosclerosis studies →

Lead sponsor

University Hospital, Antwerp is the lead sponsor of 234 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
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

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

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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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
124 participants (actual)
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Study locations

1 site
  • Universitair Ziekenhuis Antwerpen
    Edegem, Antwerpen 2650, Belgium
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00493597
Lead sponsor
University Hospital, Antwerp
Responsible party
Steven Haine (Dr.S.Haine, University Hospital, Antwerp) — Principal investigator
First posted
Jun 28, 2007
Start date
Oct 2007
Primary completion
Oct 26, 2020
Completion
Oct 26, 2020
Last update
Nov 4, 2022

Study contacts

Steven E Haine, MD
principal investigator · UZ Antwerpen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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