Blood Endothelium Progenitor Cells and Dendritic Cells as Predictive Biomarkers of In-stent Restenosis
1 other identifier
observational
124
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2007
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 27, 2007
CompletedFirst Posted
Study publicly available on registry
June 28, 2007
CompletedStudy Start
First participant enrolled
October 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 26, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 26, 2020
CompletedNovember 4, 2022
November 1, 2022
13.1 years
June 27, 2007
November 3, 2022
Conditions
Keywords
Eligibility Criteria
Non-diabetic patients scheduled for PCI with a single bare metal stent in a significant de novo coronary lesion
You may qualify if:
- 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
You may not qualify if:
- 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
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universitair Ziekenhuis Antwerpen
Edegem, Antwerpen, 2650, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steven E Haine, MD
UZ Antwerpen
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.S.Haine
Study Record Dates
First Submitted
June 27, 2007
First Posted
June 28, 2007
Study Start
October 1, 2007
Primary Completion
October 26, 2020
Study Completion
October 26, 2020
Last Updated
November 4, 2022
Record last verified: 2022-11