Blood Endothelium Progenitor Cells and Dendritic Cells as Predictive Biomarkers of in-Stent Restenosis
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by University Hospital, Antwerp.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University Hospital, Antwerp
Information provided by:
University Hospital, Antwerp
ClinicalTrials.gov Identifier:
NCT00493597
First received: June 27, 2007
Last updated: January 30, 2009
Last verified: October 2007
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Purpose
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 |
|---|
|
Atherosclerosis Restenosis |
| Study Type: | Observational |
| Study Design: | 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. |
Resource links provided by NLM:
Further study details as provided by University Hospital, Antwerp:
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
No publications provided
| Responsible Party: | Haine, Steven, MD, University Hospital of Antwerp |
| ClinicalTrials.gov Identifier: | NCT00493597 History of Changes |
| Other Study ID Numbers: | EC 7/5/36 |
| Study First Received: | June 27, 2007 |
| Last Updated: | January 30, 2009 |
| Health Authority: | Belgium: Institutional Review Board |
Keywords provided by University Hospital, Antwerp:
|
Atherosclerosis Restenosis EPC DC |
Additional relevant MeSH terms:
|
Atherosclerosis Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013