Genetic Factors in Atherosclerosis

NCT00359307 | Completed

• 2 other identifiers: 00014300-I-0143
• Study Type: observational
• Target: 1,888
• Locations: 1 country
• Sites: 1

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.

Conditions

Atherosclerosis

Keywords

Genetic; Longitudinal; Prospective; Epidemiology; Heart Attack

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Atherosclerosis; Myocardial Infarction

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Myocardial Ischemia; Heart Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• David H McDermott, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 1, 2006
• First Posted: August 2, 2006
• Study Start: June 8, 2000
• Study Completion: March 21, 2013
• Last Updated: December 17, 2019

Record last verified: 2013-03-21

Locations

US (1)