- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00359307
Genetic Factors in Atherosclerosis
Chemokine System Polymorphisms and Risk of Atherosclerosis (CAD)
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.
Přehled studie
Postavení
Podmínky
Detailní popis
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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Maryland
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Bethesda, Maryland, Spojené státy, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
- 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)
Studijní plán
Jak je studie koncipována?
Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Dokončení studie
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 000143
- 00-I-0143
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