Genetics of Peripheral Artery Genomics

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.

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Key information

Conditions

Peripheral Artery Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Behavior Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Hypertension Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Peripheral Arterial Disease Peripheral Vascular Diseases Renal Insufficiency Smoking Urogenital Diseases Urologic Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Discover novel gene expression pattern in peripheral arterial disease

Time frame: ongoing

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Genetics of Peripheral Artery Disease

Important dates

Study start: 2004
Primary completion: 2016
Study completion: 2016
First posted: Feb 14, 2008
Registry last updated: Jan 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed