AtherosclerosisNCT00493597
Blood Endothelium Progenitor Cells and Dendritic Cells as Predictive Biomarkers of In-stent Restenosis
An observational study of Atherosclerosis and Restenosis, run by University Hospital, Antwerp at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Atherosclerosis, Restenosis
- How many people
- 124 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2007to 26 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Non-diabetic patients scheduled for PCI with a single bare metal stent in a significant de novo coronary lesion
Who may be able to join
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Blood Endothelium Progenitor Cells and Dendritic Cells as Novel Predictive Biomarkers of In-stent Restenosis After Percutaneous Coronary Intervention.
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.
- Conditions
- Atherosclerosis, Restenosis
- Keywords
- Atherosclerosis, Restenosis, EPC, DC
- Medical subject headings
- Atherosclerosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2007 (estimated)
- Study startOct 2007
- Primary completion26 Oct 2020
- Study completion26 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven Haine, University Hospital, Antwerp
- Investigators
- Steven E Haine, MD, Principal investigator, UZ Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00493597
- Sponsor's protocol ID
- EC 7/5/36
- Status last verified
- Nov 2022
- First submitted
- 27 Jun 2007
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Endothelium Progenitor Cells and Dendritic Cells as Novel Predictive Biomarkers of In-stent Restenosis After Percutaneous Coronary Intervention.
- ClinicalTrials.gov ID
- NCT00493597
- Acronym / sponsor ID
- EC 7/5/36
- Conditions
- Atherosclerosis, Restenosis
- Keywords
- Atherosclerosis, Restenosis, EPC, DC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- 26 Oct 2020 (actual)
- Study completion
- 26 Oct 2020 (actual)
- First posted
- 28 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Non-diabetic patients scheduled for PCI with a single bare metal stent in a significant de novo coronary lesion
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven E Haine, MD principal investigator
UZ Antwerpen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis and Restenosis, run by University Hospital, Antwerp at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022.