Evaluation of Vascular Regeneration After a Drug Eluting Stent Implantation

Completed

• Conditions: Stable Angina

• Registration Number: NCT03214900
• Lead Sponsor: Hospital San Carlos, Madrid

Brief Summary

This is a prospective cohort, one center. twenty patients who will undergo percutaneous stent implantation with everolimus eluting stent will be include. The primary endpoint was the correlation between the change (baseline vs. 1 week) in the number of circulating endothelial progenitor cells and in cell functionality following an everolimus eluting stent implantation with the grade of neointimal hyperplasia measured by optical coherence tomography

Detailed Description

For the purpose of the study, flow cytometry analyses will be performed before intervention, at 1 week, 1 month and 9 months. In addition, cell functionality analyses will be performed by quantification of colony forming units, aldehidrodehidrogenase activity, cell proliferation by WST-1 and senescence by !-galactosidase enzyme. At 9 months the degree of neointimal proliferation will be measured by optical coherence tomography . A clinical follow-up will be performed at 1 year. Secondary endpoints include: 1. to correlate the change in the number and cell functionality of circulation progenitor cells following everolimus eluting stent and the injury score analyses measured by optical coherence tomography, and the percentage of non covered struts by optical coherence tomography at 9 months.

2.-. To evaluate the role of other subtypes of cells CD 133+/Kinase Insert Domain Receptor (KDR+), CD 14+, mesenchymal stem cells, endothelial cell markers (VE cadherina, P1H12), integrin expression of Macrophage-1 antigen (MAC-1) and the development of neointimal hyperplasia.

Study Timeline

• Study Start: 2012-07-01
• Primary Completion: 2014-07-01
• Study Completion: 2016-12-31
• Study First Submitted: 2017-06-25
• Status Verified: 2017-07
• Study First Submitted QC: 2017-07-08
• Study First Posted: 2017-07-12
• Last Update Submitted: 2017-07-13
• Last Update Posted: 2017-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients who present stable angina, silent ischemia or unstable angina whenever there is no elevation of markers of myocardial damage above the limit of normality
• Presence of at least one severe coronary stenosis (> 70% by visual analysis), susceptible of percutaneous treatment with stent implantation and an optical coherence Tomography study
• All patients should be taking statins at least 2 months prior to their inclusion in the study.

Exclusion Criteria

• Age under 18 years and pregnant or fertile age,
• Patients with ST-elevation myocardial infarction or non-ST-elevation acute coronary syndrome with markers of recent myocardial damage (<3 months),
• Patients in whom a drug-eluting stent and a bare stent have been implanted in the same procedure.
• Percutaneous treatment of restenotic lesions or total chronic occlusions.
• The use of stent pre-implantation ablation techniques (rotablator, directional atherectomy).
• Chronic renal insufficiency with serum creatinine greater than or equal to 2.5.
• Coronary revascularization in previous 3 months.
• Severe ventricular dysfunction (<25%).
• Major trauma or surgery in the previous 3 months.
• Previous organ transplantation, active neoplastic process or inflammatory disease, treatment with immunosuppressors.
• Contraindication or allergy to thienopyridines.
• Life expectancy less than one year.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The correlation between the change (baseline vs 1 week) of circulating with neointimal hyperplasia endothelial progenitor cells and in cell functionality following an Everolimus eluting stent implantation with the grade of neointimal hyperplasia	9 months	Correlation between the change (baseline vs 1 week) in the number of circulating endothelial progenitor cells and in cell functionality following an everolimus eluting stent implantation with the grade of neointimal hyperplasia measured by optical coherence Tomography

Secondary Outcome Measures

Name	Time	Method
to evaluate endothelial cell markers with neointimal hyperplasia	9 months	the role of endothelial cell markers (VE cadherin, P1H12) following an everolimus eluting stent implantation with the grade of neointimal hyperplasia measured by optical coherence Tomography
to evaluate integrin expression of MAC-1 (Macrophage-1 antigen) with neointimal hyperplasia	9 months	the role of integrin expression of MAC-1(Macrophage-1 antigen) following an everolimus eluting stent implantation with the grade of neointimal hyperplasia measured by optical coherence Tomography
to correlate number of cell and functionality of progenitor cells and injury score following everolimus eluting stent	baseline	to correlate the number and cell functionality of progenitor cells following everolimus eluting stent and the injury score analyses measured by optical coherence tomography
to evaluate other subtypes of cells with neointimal hyperplasia	9 months	the role of other subtypes of cells CD 14+ following an everolimus eluting stent implantation with the grade of neointimal hyperplasia measured by optical coherence Tomography