- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00106457
20 Year Changes in Fitness & Cardiovascular Disease Risk - Ancillary to CARDIA
Studieoversigt
Status
Detaljeret beskrivelse
BACKGROUND:
Although an age-related decline in aerobic capacity is well documented, the impact of physical activity, body fat, and genetic variation on the rate of change is not well understood. In addition, little is known about how rate of change in aerobic capacity during early and middle adulthood affects the development of cardiovascular disease risk factors or the incidence of subclinical and clinical cardiovascular disease (CVD) related end-points. The study addresses these issues by conducting an ancillary study in conjunction with the Year 20 CARDIA (Coronary Artery Risk Development in Young Adults) examination, which is scheduled to take place beginning in June, 2005. Approximately 3,650 (75%) of the surviving members of the initial cohort of African American and white men and women will return for the Year 20 exam, at which point they will be 38-50 years old.
CARDIA is a National Heart, Lung, and Blood Institute-supported longitudinal study which measures changes in coronary heart disease risk factors in cohorts of Black and white males and females who were 18 to 30 years of age at baseline. Also, the study identifies life styles during this age span which influence these changes in risk factors.
DESIGN NARRATIVE:
The overall goal of the ancillary study is to understand the complex, longitudinal relations between physical fitness, physical activity, body mass and composition and fat distribution, and genetic factors and their independent or interactive effects on the development of obesity, the metabolic syndrome, and sub-clinical CVD. To accomplish this goal, all Year 20 CARDIA participants will be measured for: 1. Aerobic capacity, by means of a symptom-limited graded exercise treadmill test, using the same protocol as that used in CARDIA at the Year 0 and Year 7 exams; 2. Body composition and fat distribution, using a whole body dual energy x-ray absorptiometery (DEXA) scan; 3. Physical activity, using 7 days of accelerometer recordings; and 4. DNA sequence variants in selected candidate genes associated with cardiorespiratory fitness, components of the metabolic syndrome, and response to regular exercise, using stored DNA.
Data from this ancillary study will be combined with core CARDIA examination data to address the following aims: a. Examination of the contribution of body mass and composition, fat distribution, objectively measured physical activity and specific genetic polymorphisms to the variance in Year 20 aerobic capacity and in age-related decline in aerobic capacity over a 20-year time period from young adulthood to mid-life, stratifying by race and gender. b. Longitudinal examination of the effect of aerobic capacity on changes in cardiovascular disease risk factors and on the incidence of CVD-related endpoints (e.g. hypertension, metabolic syndrome, subclinical disease [e.g. coronary artery calcium]).
Undersøgelsestype
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Samarbejdspartnere og efterforskere
Efterforskere
- Stephen Sidney, Kaiser Foundation Research Institute
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1290
- R01HL078972-04 (U.S. NIH-bevilling/kontrakt)
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Kliniske forsøg med Hjerte-kar-sygdomme
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Ottawa Hospital Research InstituteAfsluttetStress | Crisis Resource Management (CRM) færdigheder | Advanced Cardiovascular Life Support (ACLS) færdighederCanada