Understanding the Genetic Basis of Atherosclerosis and 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.

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Key information

Conditions

Peripheral Vascular Diseases Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Arterial Disease Vascular Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford University, Stanford, California, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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)

Treatment and study plan

Primary outcomes

Identifying genetic variations that may cause inherited differences in plaque distribution

Time frame: Measured at participants' study visit

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

The Genetic Determinants of Peripheral Arterial Disease

Acronym: GenePAD

Important dates

Study start: 2004
Primary completion: 2008
First posted: Sep 25, 2006
Registry last updated: May 28, 2015

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