Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00341562
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2006-06-19
Brief Title:
Genomics of In-Stent Restenosis
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Genomics of In-Stent Restenosis Endarterectomy Study
Status:
COMPLETED
Status Verified Date:
2006-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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
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 patients 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
Detailed Description:
Our laboratory is investigating the genetic basis of the vascular disease in-stent restenosis We hypothesize that patients with in-stent restenosis have abnormal expression of cell cycle regulatory and inflammatory genes that lead to accelerated development of vascular lesions following angioplasty and that there is a genetic component underlying individual differences to vascular injury We are conducting an investigation of human subjects with in-stent restenosis entitled the CardioGene Study The objective of the CardioGene study is to identify the genetic profile of patients at risk for in-stent restenosis The CardioGene study completed enrollment of 465 patients in December 2004 Analysis of blood gene expression profiles proteomic and genotyping data is currently ongoing All analyses are conducted using peripheral blood Concurrent analysis of restenosis tissue samples would be valuable in defining the molecular genetics of the disease
In this complementary study of endartectomy tissues we will collect diseased restenosis tissues removed from patients as part of their routine clinical care We will also collect blood at the time of tissue harvesting for genomic analysis in addition to clinical data Genomic data will be compared to the CardioGene study findings for the purposes of validation as well as more detailed understanding of the biology of restenosis by investigation the molecular mechanisms of restenosis in the tissue samples
In this complementary study of endartectomy tissues we will collect diseased restenosis tissues removed from patients as part of their routine clinical care We will also collect blood at the time of tissue harvesting for genomic analysis in addition to clinical data Genomic data will be compared to the CardioGene study findings for the purposes of validation as well as more detailed understanding of the biology of restenosis by investigation the molecular mechanisms of restenosis in the tissue samples
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-H-N234 | None | None | None |