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Genetics of Peripheral Artery Genomics
This study is currently recruiting participants.
Verified by Duke University, February 2008
Sponsored by: Duke University
Information provided by: Duke University
ClinicalTrials.gov Identifier: NCT00615121
  Purpose

Peripheral artery disease is a disease that contributes to significant morbidity and mortality of millions of Americans yearly. Very little is known about the pathophysiology of atherosclerosis in peripheral artery disease. We plan to collect peripheral arteries from patients undergoing amputation for end stage peripheral arterial occlusive disease. By extracting the RNA from these arteries and comparing them with RNA expression from normal arteries, we hope to have a better understanding of the pathophysiology of atherosclerosis in this setting. We aim to prove the hypothesis that a novel gene expression pattern can be discovered by the successful extraction of RNA from plaques from human peripheral arteries.


Condition
Peripheral Artery Disease

MedlinePlus related topics: Smoking and Youth
U.S. FDA Resources
Study Type: Observational
Study Design: Case Control, Cross-Sectional
Official Title: Genetics of Peripheral Artery Disease

Further study details as provided by Duke University:

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

Peripheral artery samples collected from patients are stored in -80celcius refrigerator for future analysis.


Estimated Enrollment: 100
Study Start Date: June 2004
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
peripheral arteries from patients undergoing amputation for end stage peripheral arterial occlusive disease
2
peripheral arteries from patients without evidence of peripheral arterial occlusive disease

Detailed Description:

Patients scheduled to undergo lower extremity amputation will be consented for extraction of plaque from the carotid artery or arterial tissue from the amputated limbs. The surgeon will perform the amputation, then the harvest team will collect arterial tissue from amputated limbs. These samples will be immersed in RNALater solution to preserve the integrity of the RNA. Tissues will stored at -80oC in the RNALater until the RNA is later extracted using a standardized protocol. The RNA will be examined for quality using an Agilent bioanalyzer, and will then be processed on Affymetrix U133A chips for gene expression data. The data will be analyzed with the MATLAB software package.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients with peripheral artery occlusive disease.

Criteria

Inclusion Criteria:

  • Patients undergoing amputations for peripheral artery disease
  • Patients undergoing free fibular transfer

Exclusion Criteria:

  • those that are not able to consent to the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00615121

Contacts
Contact: Bantayehu Sileshi, MD (919) 668-6112 bantayehu.sileshi@duke.edu
Contact: Suzanne Finley (919) 681-1093 finle008@mc.duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Principal Investigator: Jeffrey H Lawson, MD, PhD            
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Jeffrey H Lawson, MD, PhD Duke University
  More Information

Responsible Party: Duke University Medical Center ( Jeffrey H. Lawson, MD, Ph.D )
Study ID Numbers: 4814-07
Study First Received: February 3, 2008
Last Updated: February 3, 2008
ClinicalTrials.gov Identifier: NCT00615121  
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Smoking
Hypertension
Diabetes
Cardiovascular disease
Renal Failure

Study placed in the following topic categories:
Smoking
Diabetes Mellitus
Hypertension
Kidney Failure

ClinicalTrials.gov processed this record on January 14, 2009