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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by National Heart, Lung, and Blood Institute (NHLBI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00380185
First received: September 22, 2006
Last updated: February 11, 2009
Last verified: February 2009

September 22, 2006
February 11, 2009
April 2004
June 2009   (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 ] [ Designated as safety issue: No ]
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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.
 
Active, not recruiting
2000
June 2009
June 2009   (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)
Both
40 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00380185
1361, R01 HL075774-04
Not Provided
Dr. John P. Cooke, MD, PhD, Stanford School of Medicine
National Heart, Lung, and Blood Institute (NHLBI)
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Principal Investigator: John P. Cooke, MD, PhD Stanford University
National Heart, Lung, and Blood Institute (NHLBI)
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP