CompletedNot Applicable

Blood Endothelium Biomarkers to Predict Major Adverse Cardiovascular Events After Percutaneous Coronary Intervention

France170 participantsStarted 2007-09

Plain-language 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. 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.

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 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 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 * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

Timeframe: 36 months

Trial details

NCT IDNCT00725868

SponsorAssistance Publique Hopitaux De Marseille

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-08

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