Genomics of In-Stent Restenosis

NCT00341562 | Completed

• 2 other identifiers: 99990523405-H-N234
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study, conducted in Argentina at the Hospital Espa ol de la Plata and the Hospital Franc s de Buenos Aires, in collaboration with the NHLBI, will investigate possible genetic factors that lead to in-stent restenosis. A stent is a wire mesh tube that is surgically placed to open a blocked artery. The stent stays in the artery permanently, holding it open to improve blood flow. In the case of blocked coronary arteries, the stent improves blood flow to the heart muscle, relieving symptoms such as chest pain and shortness of breath. Sometimes re-growth of tissue within a stent, called in-stent restenosis, leads to narrowing of the artery, decreased blood flow, and a recurrence of symptoms. Genetic analysis may allow the identification of patient that may be at increased risk for in-stent restenosis and lead to methods of prevention and treatment. Patients 18 years of age and older who are undergoing coronary endarterectomy (surgery to remove plaque from an artery) to treat in-stent restenosis at the Hospital Espa ol de la Plata and the Hospital Franc s de Buenos Aires may be eligible for this study. Participants will have a blood sample drawn and undergo coronary endarterectomy. Tissue removed from the patient's artery or the stent during surgery will be analyzed for gene expression profiling and genotyping. The results will be studied along with information about the patients' medical history.

Conditions

In-Stent Restenosis; Vascular Disease

Keywords

Gene Expression Profiling; Vascular Disease

Eligibility Criteria

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

You may qualify if:

• Patients 18 years of age or older
• Patients undergoing coronary endarterectomy as part of their course of medical therapy. The lesion for which endarterectomy is being performed is restenosis within a bare metal stent within a native coronary artery

You may not qualify if:

• Current enrollment in a clinical trial for the treatment or prevention of in-stent restenosis.
• Lesion within saphenous vein graft following coronary artery bypass grafting
• Patients younger than 18 years of age
• The patient is unable to provide informed consent

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Heart, Lung and Blood Institute (NHLBI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• Hayashi S, Watanabe N, Nakazawa K, Suzuki J, Tsushima K, Tamatani T, Sakamoto S, Isobe M. Roles of P-selectin in inflammation, neointimal formation, and vascular remodeling in balloon-injured rat carotid arteries. Circulation. 2000 Oct 3;102(14):1710-7. doi: 10.1161/01.cir.102.14.1710.

  PMID: 11015352 BACKGROUND

MeSH Terms

Conditions

Vascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 21, 2006
• Study Start: September 1, 2005
• Study Completion: July 1, 2006
• Last Updated: March 4, 2008

Record last verified: 2006-07

Locations

US (1)