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

Sponsor

University Hospital, Antwerp (Other)

Overall Status

Unknown status

CT.gov ID

NCT00493597

Collaborator

(none)

250

Enrollment

Location

Study Details

Study Description

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	Intervention/Treatment	Phase
Atherosclerosis Restenosis

Study Design

Study Type:

Observational

Anticipated 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 :

Oct 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Universitair Ziekenhuis Antwerpen	Edegem	Antwerpen	Belgium	2650

Sponsors and Collaborators

University Hospital, Antwerp

Investigators

Principal Investigator: Steven E Haine, MD, UZ Antwerpen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00493597

Other Study ID Numbers:

EC 7/5/36

First Posted:

Jun 28, 2007

Last Update Posted:

Feb 2, 2009

Last Verified:

Oct 1, 2007

Keywords provided by , ,

Atherosclerosis

Restenosis

EPC

Additional relevant MeSH terms:

Atherosclerosis

Study Results

No Results Posted as of Feb 2, 2009