AtherosclerosisNCT00725868
Blood Endothelium Biomarkers to Predict Major Adverse Cardiovascular Events After Percutaneous Coronary Intervention
A study testing Data private hospitals, angioplasty, sampling of blood in people with Atherosclerosis and Percutaneous Coronary Intervention, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
In stent restenosis and myocardial infarction are have been linked the balance between injury and healing of the endothelium These processes can be measured respectively using the number of circulating endothelial cells and endothelial progenitor cells. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Atherosclerosis, Percutaneous Coronary Intervention, Cardiovascular Diseases
- What is being tested?
- Data private hospitals, angioplasty, sampling of blood
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2007to Dec 2010
- Phase
- Interventional
- 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
Who may be able to join
- Age>18 years old
- Scheduled for PCI
- Clinical evidence of ischemic heart disease and/or abnormal functional study
- New coronary artery lesion >50%
- treatment with bare metal stent planned
- 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 coronary syndrome (ST-elevation or not) in the past month
- Planned drug eluting stent implantation
- Lesion in arterial or venous bypass or anastomosis with coronary
Show all 14Show fewer
- Severe renal insufficiency (creatinine clearance <30 mL/')
- Severe hepatic insufficiency
- Systemic inflammatory pathology of any kind
- Hematologic or other malignancy, prior radio- or chemotherapy
- Use of corticosteroïds or immune suppression therapy
- Contrast allergy
- 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 Biomarkers to Predict Major Adverse Cardiovascular Events After Percutaneous Coronary Intervention.
In stent restenosis and myocardial infarction are have been linked the balance between injury and healing of the endothelium These processes can be measured respectively using the number of circulating endothelial cells and endothelial progenitor cells. We therefore aimed to evaluate the relationship between the balance of injury and healing of the endothelium at the time of PCI and major adverse cardiovascular events including death, myocardial infarction and target lesion revascularization at 6 and 12 months follow-up.
Read the detailed description
Following percutaneous coronary intervention with bare metal stents, the rate of major adverse cardiovascular events including death, myocardial infarction and target lesion revascularization is high ranging between 20 and 25%.
- Being tested
- Data private hospitals, angioplasty, sampling of blood
- Keywords
- Major adverse
- Medical subject headings
- Atherosclerosis, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data private hospitals, angioplasty, sampling of bloodOther
- Data private hospitals : Age, sex, index of body mass, factors of cardiovascular risk, medical surgical histories, treatment before and after the angioplasty, the renal insufficiency
- coronary angioplasty
- Sampling of blood : Before the angioplasty, 6 hours after the angioplasty and 24 hours after the angioplasty. A numeration of the proparents circulants (hématopoietics, PEC) and a numeration of CEC are made
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Data private hospitals, angioplasty, sampling of blood Receives: Other: Data private hospitals, angioplasty, sampling of blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main objective of this study is to estimate if the measure of CEC and PEC possesses a meaning forecast towards the arisen of complications post procedure.
Measured: 36 months
Secondary outcomes (1)
To determine the relation between these endothelial biomarkers and the other usual parameters forecast complications post-angioplasty
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2008 (estimated)
- Study startSep 2007
- Primary completionAug 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Franck PAGANELLI, MD, Principal investigator, Assistance Publique des Hopitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00725868
- Sponsor's protocol ID
- 2007-A00533-50
- Other IDs
- 2007-18
- Status last verified
- Aug 2011
- First submitted
- 30 Jul 2008
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Bonello L, Harhouri K, Sabatier F, Camoin-Jau L, Arnaud L, Baumstarck-Barrau K, Ait-Mokhtar O, Roubille F, Piot C, Lesavre N, Paganelli F, Dignat-George F. Level of adenosine diphosphate receptor P2Y12 blockade during percutaneous coronary intervention predicts the extent of endothelial injury, assessed by circulating endothelial cell measurement. J Am Coll Cardiol. 2010 Sep 21;56(13):1024-31. doi: 10.1016/j.jacc.2010.01.072.
PubMed 20846600
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Endothelium Biomarkers to Predict Major Adverse Cardiovascular Events After Percutaneous Coronary Intervention.
- ClinicalTrials.gov ID
- NCT00725868
- Acronym / sponsor ID
- 2007-A00533-50
- Keywords
- Major adverse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Aug 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 31 Jul 2008 (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.
In stent restenosis and myocardial infarction are have been linked the balance between injury and healing of the endothelium These processes can be measured respectively using the number of circulating endothelial cells and endothelial progenitor cells. We therefore aimed to evaluate the relationship between the balance of injury and healing of the endothelium at the time of PCI and major adverse cardiovascular events including death, myocardial infarction and target lesion revascularization at 6 and 12 months follow-up.
Detailed description
Following percutaneous coronary intervention with bare metal stents, the rate of major adverse cardiovascular events including death, myocardial infarction and target lesion revascularization is high ranging between 20 and 25%.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: Data private hospitals, angioplasty, sampling of bloodData private hospitals, angioplasty, sampling of blood |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age>18 years old
- Scheduled for PCI
- Clinical evidence of ischemic heart disease and/or abnormal functional study
- New coronary artery lesion >50%
- treatment with bare metal stent planned
Key exclusion criteria (14 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 coronary syndrome (ST-elevation or not) in the past month
- Planned drug eluting stent implantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data private hospitals, angioplasty, sampling of blood* Data private hospitals : Age, sex, index of body mass, factors of cardiovascular risk, medical surgical histories, treatment before and after the angioplasty, the renal insufficiency * coronary angioplasty * Sampling of blood : Before the angioplasty, 6 hours after the angioplasty and 24 hours after the angioplasty. A numeration of the proparents circulants (hématopoietics, PEC) and a numeration of CEC are made | Other | 1 |
Primary outcome
The main objective of this study is to estimate if the measure of CEC and PEC possesses a meaning forecast towards the arisen of complications post procedure.
Time frame: 36 months
1 secondary outcome
To determine the relation between these endothelial biomarkers and the other usual parameters forecast complications post-angioplasty
Time frame: 36 months
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 7 May 2026.
- Results publication: PubMed 20846600Bonello L, Harhouri K, Sabatier F, Camoin-Jau L, Arnaud L, Baumstarck-Barrau K, Ait-Mokhtar O, Roubille F, Piot C, Lesavre N, Paganelli F, Dignat-George F. Level of adenosine diphosphate receptor P2Y12 blockade during percutaneous coronary intervention predicts the extent of endothelial injury, assessed by circulating endothelial cell measurement. J Am Coll Cardiol. 2010 Sep 21;56(13):1024-31. doi: 10.1016/j.jacc.2010.01.072.
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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.
Franck PAGANELLI, MD principal investigator
Assistance Publique des Hopitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Data private hospitals, angioplasty, sampling of blood in people with Atherosclerosis and Percutaneous Coronary Intervention, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 6 inclusion and 14 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 7 May 2026. 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 France. 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.
What does the primary outcome measure?
The main objective of this study is to estimate if the measure of CEC and PEC possesses a meaning forecast towards the arisen of complications post procedure. (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00725868, which also lists 1 linked publication.
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 7 May 2026.