Evaluation of Vascular Regeneration After a Drug Eluting Stent Implantation

NCT03214900 | Completed DMC

• 1 other identifier: PI11/00299
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

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

Conditions

Stable Angina

Outcome Measures

Primary Outcomes (1)

• 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

  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

  9 months

Secondary Outcomes (5)

• to correlate number of cell and functionality of progenitor cells and injury score following everolimus eluting stent

  baseline

• to evaluate other subtypes of cells with neointimal hyperplasia

  9 months

• to evaluate other subtypes of cells with neointimal hyperplasia

  9 months

• to evaluate endothelial cell markers with neointimal hyperplasia

  9 months

• to evaluate integrin expression of MAC-1 (Macrophage-1 antigen) with neointimal hyperplasia

  9 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

stable angina

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital San Carlos, Madrid: lead
• Instituto de Salud Carlos III: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples

MeSH Terms

Conditions

Angina, Stable

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Principal Investigator

Study Record Dates

• First Submitted: June 25, 2017
• First Posted: July 12, 2017
• Study Start: July 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: December 31, 2016
• Last Updated: July 18, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share