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Genetic Factors in Atherosclerosis

Primary Purpose

Atherosclerosis

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Atherosclerosis focused on measuring Genetic, Longitudinal, Prospective, Epidemiology, Heart Attack

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA: Free of acute and chronic diseases (especially GI disorders) as determined by medical history, physical examination and laboratory tests. Individuals may be taking antacids and/or laxative drugs but they must be discontinued 3 or more weeks before admission. Age 18-45 years (in order to minimize the effect of aging on nutrient absorption). BMI 18-25 kg/m(2) or greater than 35 kg/m(2). EXCLUSION CRITERIA: History or clinical manifestation of: Current smoking Type 2 diabetes (according to the World Health Organization diagnostic criteria) Endocrine disorders, such as Cushing's disease, pituitary disorders, and hypo- and hyperthyroidism HIV infection (self-report), due to effects on weight and body composition of HIV and medications used to treat HIV Active tuberculosis (self-report) Pulmonary disorders, including physician diagnosed chronic obstructive pulmonary diseases and obstructive sleep apnea syndrome; only subjects with mild or exercise-induced asthma on no medications or on beta-adrenergic agonists only (such as albuterol) will be allowed to enter the study Cardiovascular diseases, including coronary heart disease, heart failure, arrhythmias, and peripheral artery disease Hypertension (according to the World Health Organization diagnostic criteria), treated or uncontrolled Gastrointestinal disease, including inflammatory bowel diseases (e.g. Crohn's disease and ulcerative colitis), malabsorption syndromes (e.g. celiac disease), gastric ulcer (active) Lactose intolerance Liver disease, including non-alcoholic fatty liver disease, AST or ALT greater than 1.5 x normal value, cirrhosis, active hepatitis B or C Renal disease, as defined by serum creatinine concentrations greater than 1.5 mg/dl and/or overt proteinuria Central nervous system disease, including previous history of cerebrovascular accidents, dementia, and neurodegenerative disorders Cancer requiring treatment in the past five years, except for non-melanoma skin cancers or cancers that have clearly been cured or, in the opinion of the investigator, carry an excellent prognosis Behavioral or psychiatric conditions that would be incompatible with a safe and successful participation in the study (such as major depression, schizophrenia and presence of psychotic symptoms) Taking weight loss drugs Use of any antibiotic or probiotic agents within the 2 months prior to the study Evidence of alcohol and/or drug abuse (more than 3 drinks per day and use of drugs, such as amphetamines, cocaine, heroin, or marijuana)

Sites / Locations

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 1, 2006
Last Updated
December 14, 2019
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00359307
Brief Title
Genetic Factors in Atherosclerosis
Official Title
Chemokine System Polymorphisms and Risk of Atherosclerosis (CAD)
Study Type
Observational

2. Study Status

Record Verification Date
March 21, 2013
Overall Recruitment Status
Completed
Study Start Date
June 8, 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 21, 2013 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis
Keywords
Genetic, Longitudinal, Prospective, Epidemiology, Heart Attack

7. Study Design

Enrollment
1888 (Actual)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA: Free of acute and chronic diseases (especially GI disorders) as determined by medical history, physical examination and laboratory tests. Individuals may be taking antacids and/or laxative drugs but they must be discontinued 3 or more weeks before admission. Age 18-45 years (in order to minimize the effect of aging on nutrient absorption). BMI 18-25 kg/m(2) or greater than 35 kg/m(2). EXCLUSION CRITERIA: History or clinical manifestation of: Current smoking Type 2 diabetes (according to the World Health Organization diagnostic criteria) Endocrine disorders, such as Cushing's disease, pituitary disorders, and hypo- and hyperthyroidism HIV infection (self-report), due to effects on weight and body composition of HIV and medications used to treat HIV Active tuberculosis (self-report) Pulmonary disorders, including physician diagnosed chronic obstructive pulmonary diseases and obstructive sleep apnea syndrome; only subjects with mild or exercise-induced asthma on no medications or on beta-adrenergic agonists only (such as albuterol) will be allowed to enter the study Cardiovascular diseases, including coronary heart disease, heart failure, arrhythmias, and peripheral artery disease Hypertension (according to the World Health Organization diagnostic criteria), treated or uncontrolled Gastrointestinal disease, including inflammatory bowel diseases (e.g. Crohn's disease and ulcerative colitis), malabsorption syndromes (e.g. celiac disease), gastric ulcer (active) Lactose intolerance Liver disease, including non-alcoholic fatty liver disease, AST or ALT greater than 1.5 x normal value, cirrhosis, active hepatitis B or C Renal disease, as defined by serum creatinine concentrations greater than 1.5 mg/dl and/or overt proteinuria Central nervous system disease, including previous history of cerebrovascular accidents, dementia, and neurodegenerative disorders Cancer requiring treatment in the past five years, except for non-melanoma skin cancers or cancers that have clearly been cured or, in the opinion of the investigator, carry an excellent prognosis Behavioral or psychiatric conditions that would be incompatible with a safe and successful participation in the study (such as major depression, schizophrenia and presence of psychotic symptoms) Taking weight loss drugs Use of any antibiotic or probiotic agents within the 2 months prior to the study Evidence of alcohol and/or drug abuse (more than 3 drinks per day and use of drugs, such as amphetamines, cocaine, heroin, or marijuana)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David H McDermott, M.D.
Organizational Affiliation
National Institute of Allergy and Infectious Diseases (NIAID)
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institutes of Health Clinical Center, 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

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Genetic Factors in Atherosclerosis

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