Genetics of Peripheral Artery Genomics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00615121
Recruitment Status : Completed
First Posted : February 14, 2008
Last Update Posted : January 25, 2016
Information provided by (Responsible Party):
Duke University

Brief Summary:
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 and muscle tissue from patients undergoing amputation for end stage peripheral arterial occlusive disease. By extracting the RNA from these arteries and tissues 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 or disease
Peripheral Artery 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.

Study Type : Observational
Actual Enrollment : 122 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Genetics of Peripheral Artery Disease
Study Start Date : June 2004
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

arteries from PAD patients
peripheral arteries from patients undergoing amputation for end stage peripheral arterial occlusive disease
arteries from Free Fib transfers
peripheral arteries from patients without evidence of peripheral arterial occlusive disease

Primary Outcome Measures :
  1. Discover novel gene expression pattern in peripheral arterial disease [ Time Frame: ongoing ]

Biospecimen Retention:   Samples With DNA
Peripheral artery samples collected from patients are stored in -80celcius refrigerator for future analysis.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with peripheral artery occlusive disease.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00615121

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

Responsible Party: Duke University Identifier: NCT00615121     History of Changes
Other Study ID Numbers: Pro00008270
4814-07 ( Other Identifier: Duke legacy protocol number )
First Posted: February 14, 2008    Key Record Dates
Last Update Posted: January 25, 2016
Last Verified: January 2016

Keywords provided by Duke University:
Cardiovascular disease
Renal Failure

Additional relevant MeSH terms:
Peripheral Arterial Disease
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases