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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 23, 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:

Cocaine dependent participants must meet DSM-IV criteria for cocaine dependence at the time of participation.

Control participants who provide appropriate matches for cocaine-dependent participants will be recruited on the following characteristics: age, and when possible, parental socio-economic status and/or years of parental education.

EXCLUSION CRITERIA:

Control Participants:

  1. Psychiatric disease: DSM-IV criteria will be used (American Psychiatric Association, 1994). No subject with a current axis I diagnosis (except for nicotine dependence) will be allowed. Claustrophobia is also exclusionary.
  2. History of Drug Abuse: Volunteers reporting current or having a significant history of illicit drug abuse will be excluded from the study. Subjects may use moderate amounts of alcohol and caffeine and smoke an occasional marijuana cigarette, but must not be dependent on alcohol, caffeine or marijuana. No alcohol or marijuana for at least 24 hours prior to scanning. No smoking after midnight on the night before a scan.
  3. Current or Past Medication Use: Volunteers may not currently use chronic (daily for more than 10 to 14 days in the last month) prescription or over the counter medications, (including, but not limited to, anti-hypertensive, anti-allergy, pain). Over the counter or prescription medications may be used on an occasional basis (for treatment of self-limited conditions, such as occasional headache, musculoskeletal discomfort, allergic symptoms or pain). All medications will be discontinued at least 5 days before the experimental session.
  4. CNS disease: History of known structural brain abnormalities (e.g., neoplasm, subarachnoid cysts), cerebrovascular disease, infectious disease (e.g., abscess), history of head trauma (defined as documented loss of consciousness > 5 min), history of seizures as an adult, sleep apnea, tic disorder.
  5. Cardiovascular, pulmonary, or systemic disease: Repeated (measured on three separate occasions) diastolic blood pressure >90 mm Hg, or systolic blood pressure >135 mm Hg, known arrhythmia, symptomatic or known coronary artery disease; history of endocarditis, cerebral embolism, obstructive pulmonary disease, Factive tuberculosis, known endocrine disease (derangements in adrenal, thyroid, bone or reproductive function), known chronic renal or hepatic dysfunction, HIV seropositive, known current autoimmune disease involving the CNS.
  6. Miscellaneous exclusionary criteria: Body weight greater than 300 lbs. Hematocrit < 39.0 for males or < 36.0 for females. Participants are also excluded if veins are inaccessible.
  7. Radiation exposure: Any subject who has participated in any research studies in which he/she received a radiation exposure that would result in combination with the present study, in a total effective radiation exposure (from research studies) exceeding 5.0 rem in a year.
  8. Novocain allergy or lack of bilateral ulner and radial arterial patency in subjects receiving arterial catheter as assessed by an Allen s test or Dopler test artery patency for all subjects to be catheterized.
  9. Presence in body of metallic implants or materials that could be moved by the magnet of the MRI scanner: pacemakers, surgical implants, aneurism clips, dental braces, bullet(s) or other metallic materials. A history of working with metal with consequent possible metal fragments in the body.
  10. Inability to lie flat for a few hours for the PET scans
  11. Women who are pregnant or lactating and children under the age of 18 will be excluded to avoid unnecessary exposure to radiation to these populations.

Cocaine Dependent Subjects:

In addition to the exclusion criteria listed above with the exception of item i. b), subjects in this group will be excluded if:

  1. They are actively seeking or engaged in substance abuse treatment. Justification: Videos viewed during this study may produce drug craving, producing a significant risk of relapse in a dependent individual attempting to remain abstinent. Any participant seeking treatment will be referred to treatment, since delaying entry into treatment to participate in a study unnecessarily increases exposure to the risks associated with active cocaine dependence. Assessment tool(s): Clinical interview at screening and repeat questioning at time of consent.
  2. They are dependent on other substances except nicotine or cocaine at the time of participation. Use of other abused substances will be allowed as long as they are not currently dependent on any drug except nicotine and cocaine. Justification: Dependence on other substances may result in unique CNS deficits that would increase the noise in our data. Further, other dependence may contaminate neural processes examined. Nicotine dependence will be allowed since nicotine use is not associated with a drug high in normal usage and the prevalence of nicotine dependence in cocaine using individuals may make it impractical to exclude them. Assessment tool(s): Substance Use Disorders module of the SCID with confirmation by clinical interview and negative urine drug screen. Positive screens for cocaine are allowed.

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 23, 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