Genetics of Peripheral Artery Genomics

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00615121
First received: February 3, 2008
Last updated: July 14, 2014
Last verified: July 2014
  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 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
Peripheral Artery Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Genetics of Peripheral Artery Disease

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Discover novel gene expression pattern in peripheral arterial disease [ Time Frame: ongoing ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

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 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00615121

Contacts
Contact: Dana Giangiacomo (919) 681-1092 dana.giangiacomo@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

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00615121     History of Changes
Other Study ID Numbers: Pro00008270, 4814-07
Study First Received: February 3, 2008
Last Updated: July 14, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 21, 2014