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Understanding the Genetic Basis of Atherosclerosis and Peripheral Arterial Disease (GenePAD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00380185
First Posted: September 25, 2006
Last Update Posted: May 28, 2015
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.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
John P Cooke, MD, Stanford University
September 22, 2006
September 25, 2006
May 28, 2015
April 2004
July 2008   (Final data collection date for primary outcome measure)
Identifying genetic variations that may cause inherited differences in plaque distribution [ Time Frame: Measured at participants' study visit ]
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Complete list of historical versions of study NCT00380185 on ClinicalTrials.gov Archive Site
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Understanding the Genetic Basis of Atherosclerosis and Peripheral Arterial Disease
The Genetic Determinants of Peripheral Arterial Disease
Atherosclerosis, a condition in which fatty deposits build up along the inner walls of arteries, can occur throughout the body. The purpose of this study is to examine the possible genetic differences that may influence where atherosclerosis occurs.

Plaque build-up caused by atherosclerosis increases the risk of blood clots, heart attack, and stroke. Blockages of plaque can occur in different areas of the body. PAD, a circulatory disorder in which blockages occur in the peripheral arteries, is one manifestation of atherosclerosis. Individuals with PAD experience reduced blood flow to the legs, which may cause leg pain while walking. Coronary artery disease (CAD), in which plaque builds up in arteries leading to the heart, is another atherosclerosis-related condition. Individuals with PAD and CAD have similar atherosclerosis risk factors, but it remains unknown why some individuals develop one disease and not the other. Genetic differences may influence where atherosclerosis develops. The goal of the study is to identify genetic variations that may cause inherited differences in plaque distribution.

This study will enroll individuals with PAD who have been referred by their doctor for a coronary angiogram to confirm the presence of CAD. A control group composed of individuals who do not have PAD, but have similar risk factors for atherosclerosis, will also be enrolled. All participants will attend one study visit. They will undergo a coronary angiogram, a procedure in which a special dye is inserted intravenously into an artery of the heart. X-rays will be taken to document how blood flows through the artery. Questionnaires assessing quality of life, exercise habits, tobacco exposure, and family medical history will be completed. Participants will also undergo blood pressure measurements and blood collection for genetic analysis. Yearly follow-up phone calls will occur for 5 years to document any hospitalizations.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:
Serum, Plasma, White Cells
Non-Probability Sample
Subjects are recruited from individuals undergoing elective coronary angiography for suspected CAD at Stanford University or Mount Sinai Medical Centers.
Peripheral Vascular Diseases
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  • 1
    Subjects with no hemodynamically significant disease (NHSD) of the coronary or peripheral arteries
  • 2
    Subjects with coronary artery disease only
  • 3
    Subjects with both coronary artery disease and peripheral arterial disease
Sadrzadeh Rafie AH, Stefanick ML, Sims ST, Phan T, Higgins M, Gabriel A, Assimes T, Narasimhan B, Nead KT, Myers J, Olin J, Cooke JP. Sex differences in the prevalence of peripheral artery disease in patients undergoing coronary catheterization. Vasc Med. 2010 Dec;15(6):443-50. doi: 10.1177/1358863X10388345.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1789
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July 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Hemodynamically significant PAD, as documented by an ankle-brachial index less than 0.9; control group participants will not have PAD
  • Received a referral for an elective coronary angiogram
  • Suspected CAD

Exclusion Criteria:

  • History of radiation treatment
  • History of organ transplant
  • History of viral diseases (i.e. HIV, hepatitis)
Sexes Eligible for Study: All
40 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00380185
1361
R01HL075774 ( U.S. NIH Grant/Contract )
Yes
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John P Cooke, MD, Stanford University
Stanford University
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: John P. Cooke, MD, PhD Stanford University
Stanford University
May 2015