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Genetic Factors in Atherosclerosis

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ClinicalTrials.gov Identifier: NCT00359307
Recruitment Status : Completed
First Posted : August 2, 2006
Last Update Posted : April 24, 2018
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)

Brief Summary:

The purpose of this study is to identify genes associated with certain risk factors for atherosclerosis (hardening of the arteries) and its consequences, such as development of coronary artery disease, heart attack, other blood vessel disease and stroke.

People enrolled in the Framingham Heart Study in Framingham, Massachusetts, are eligible to participate in this study. They will undergo a medical history, including review of their medical records and a family history; evaluation of memory and mood; breathing test and electrocardiogram (EKG); blood and urine tests, including blood sample collection for DNA (genetic) testing; evaluation of gait (walking), balance and hand grip strength; and hearing test. They will also fill out questionnaires on their eating habits and general health.

Any patients who may suffer a stroke during the study will be examined during their hospitalization and at 3, 6, 12, and 24 months after the stroke. This examination includes a neurological evaluation, assessment of ability to perform daily living tasks and, possibly, magnetic resonance imaging (MRI) of the brain, a test that uses a strong magnetic field and radio waves to produce pictures of the brain.


Condition or disease
Atherosclerosis

Detailed Description:
We are studying the relationship between genetic variants of the human immune system and atherosclerosis through a collaboration with the Framingham Heart Study. Since atherosclerosis is a disease of chronic inflammation of the arterial vessel wall, genetic variants in molecules that are responsible for the migration of leukocytes are likely to explain some of the genetic diversity in the rate of heart disease and strokes. Therefore we are conducting a molecular epidemiology study of the genetics of atherosclerosis using materials and clinical data already collected by the Framingham Heart Study. The Heart Study is a prospective epidemiological study of the natural history of heart disease and stroke that has involved individuals residing in Framingham, Massachusetts since the 1950s. We will compare risks of individuals with particular genotypes for developing atherosclerosis and its sequelae, coronary artery disease, heart attack, peripheral vascular disease, and stroke. If correlations of genotype with risk of atherosclerosis can be found, then this will facilitate new treatments of this disease based on interference with particular components of the human immune system.

Study Type : Observational
Actual Enrollment : 1888 participants
Official Title: Chemokine System Polymorphisms and Risk of Atherosclerosis (CAD)
Study Start Date : June 8, 2000
Study Completion Date : March 21, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis
U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

A subject must satisfy all of the following criteria to be eligible to participate in this study:

  1. Latino ethnicity. Latino ethnic background will be defined as a geographic, historical, and cultural heritage shared among persons from Spanish-speaking countries in South and Central America, Mexico, and the Caribbean. Both parents and all grandparents of the participant have to be Latino, with Spanish as the primary language. Participants have to be white; native aboriginal Indians, Asians, and blacks will be excluded.
  2. Age greater than or equal to 18 years.
  3. Documentation of hepatitis C infection by demonstration of a positive test for hepatitis C antibody and HCV RNA level of greater than or equal to 2,000 IU/mL.
  4. Documentation of HIV-1 infection in the second group of co-infected participants by a licensed enzyme-linked immunosorbent assay and confirmed by a Western blot or by HIV polymerase chain reaction positive.
  5. Participants with HIV: CD4+ cell counts greater than or equal to 100 cells/mm(3) or CD4+ cell percentage greater than or equal to 14%.
  6. Ability to provide informed consent and willingness to comply with the study requirements, storage of blood samples and clinic policies.
  7. Participants must have a primary care physician managing medical problems.
  8. For HIV infected participants, care provided by a primary physician must be consistent with the current DHHS guidelines. For those on therapy, HAART will be provided by their physician.
  9. Willing to undergo genetic testing
  10. About to start HCV treatment (with or without direct acting agents DAAs)

EXCLUSION CRITERIA:

A subject will be ineligible to participate in this study if any of the following criteria are met:

  1. Unable to comply with research study visits
  2. Have any condition that the investigator considers a contraindication to study participation.
  3. Pregnant or breastfeeding women.
  4. Patients with poor venous access

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00359307


Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: David H McDermott, M.D. National Institute of Allergy and Infectious Diseases (NIAID)

ClinicalTrials.gov Identifier: NCT00359307     History of Changes
Other Study ID Numbers: 000143
00-I-0143
First Posted: August 2, 2006    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: March 21, 2013

Keywords provided by National Institutes of Health Clinical Center (CC):
Genetic
Longitudinal
Prospective
Epidemiology
Heart Attack

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