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Pediatric Epidemiology of Cardiovascular Disease Risk Factors (Project Heartbeat)

Primary Purpose

Cardiovascular Diseases, Heart Diseases, Atherosclerosis

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Cardiovascular Diseases

Eligibility Criteria

undefined - 100 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 25, 2000
    Last Updated
    May 12, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00005264
    Brief Title
    Pediatric Epidemiology of Cardiovascular Disease Risk Factors (Project Heartbeat)
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    October 2002
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1990 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    September 1996 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. Study Description

    Brief Summary
    To conduct a longitudinal, natural history study of cardiovascular disease risk factors in children. Growth curves were compared for levels of blood pressure, lipids, cardiac structures and function, and related to physical growth and maturation, nutrient intake, physical activity, body composition, puberty, and smoking.
    Detailed Description
    BACKGROUND: Both the pathologic precursors of atherosclerosis and the development of its major risk factors -- blood pressure, blood lipids, and cigarette smoking -- are often far advanced before age 20 or within the period from birth or conception through adolescence. In 1990, there was growing interest in understanding these aspects of human biology and in devising appropriate preventive measures. In 1990, knowledge about the risk factors during childhood and adolescence was based mainly on cross-sectional surveys, from which very striking and consistent patterns of change with age were inferred, and from which reference values for screening and management were derived. Both growth and sexual maturation influence these patterns strongly, yet these risk factors had only recently been taken into account in 1990, only partially in screening recommendations for blood pressure and not at all for cholesterol. DESIGN NARRATIVE: Subjects were selected by simple random sampling. Data were collected on dependent variables including blood pressure, heart rate, echocardiography, Doppler flow, blood lipids, and smoking. Independent variables included growth, diet and nutrition, electrolytes, physical activity and fitness, personal, family, and social history, and bone age. Most observations were recorded at four month intervals. There was a six month pretest recruitment period, four years of cycled measurements and data collection, and six months of analysis and reporting. Curves for both velocity and acceleration of growth for attained levels of blood pressure, blood lipids, and smoking were determined as were longitudinal relationships between individual growth curves of blood pressure, echocardiographic measures, physical growth, sexual maturation, body composition, diet, physical activity, and social factors. Dr. Labarthe has several R03 grants to analyze data from Project Heartbeat. See also Study 4962. The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiovascular Diseases, Heart Diseases, Atherosclerosis

    7. Study Design

    10. Eligibility

    Sex
    Male
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    No eligibility criteria
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Darwin LaBarthe
    Organizational Affiliation
    University of Texas

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    7698726
    Citation
    Tanner JM, Oshman D, Lindgren G, Grunbaum JA, Elsouki R, Labarthe D. Reliability and validity of computer-assisted estimates of Tanner-Whitehouse skeletal maturity (CASAS): comparison with the manual method. Horm Res. 1994;42(6):288-94. doi: 10.1159/000184211.
    Results Reference
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    PubMed Identifier
    9193432
    Citation
    Labarthe DR, Nichaman MZ, Harrist RB, Grunbaum JA, Dai S. Development of cardiovascular risk factors from ages 8 to 18 in Project HeartBeat! Study design and patterns of change in plasma total cholesterol concentration. Circulation. 1997 Jun 17;95(12):2636-42. doi: 10.1161/01.cir.95.12.2636.
    Results Reference
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    PubMed Identifier
    9086310
    Citation
    Grunbaum JA, Labarthe DR, Ayars C, Harrist R, Nichaman MZ. Recruitment and enrollment for Project HeartBeat! Achieving the goals of minority inclusion. Ethn Dis. 1996 Autumn;6(3-4):203-12.
    Results Reference
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    PubMed Identifier
    10454447
    Citation
    Dai S, Ayres NA, Harrist RB, Bricker JT, Labarthe DR. Validity of echocardiographic measurement in an epidemiological study. Project HeartBeat! Hypertension. 1999 Aug;34(2):236-41. doi: 10.1161/01.hyp.34.2.236.
    Results Reference
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    PubMed Identifier
    10094101
    Citation
    Fulton JE, Dai S, Grunbaum JA, Boerwinkle E, Labarthe DR. Apolipoprotein E affects serial changes in total and low-density lipoprotein cholesterol in adolescent girls: Project HeartBeat! Metabolism. 1999 Mar;48(3):285-90. doi: 10.1016/s0026-0495(99)90073-2.
    Results Reference
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    PubMed Identifier
    9255189
    Citation
    Tanner J, Oshman D, Bahhage F, Healy M. Tanner-Whitehouse bone age reference values for North American children. J Pediatr. 1997 Jul;131(1 Pt 1):34-40. doi: 10.1016/s0022-3476(97)90000-7. Erratum In: J Pediatr. 2012 Dec;161(6):1180.
    Results Reference
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    PubMed Identifier
    12370160
    Citation
    Dai S, Labarthe DR, Grunbaum JA, Harrist RB, Mueller WH. Longitudinal analysis of changes in indices of obesity from age 8 years to age 18 years. Project HeartBeat! Am J Epidemiol. 2002 Oct 15;156(8):720-9. doi: 10.1093/aje/kwf109.
    Results Reference
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    PubMed Identifier
    11533935
    Citation
    Mueller WH, Harrist RB, Doyle SR, Ayars CL, Labarthe DR. Body measurement variability, fatness, and fat-free mass in children 8, 11, and 14 years of age: Project HeartBeat! Am J Hum Biol. 1999;11(1):69-78. doi: 10.1002/(SICI)1520-6300(1999)11:13.0.CO;2-T.
    Results Reference
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    PubMed Identifier
    11400224
    Citation
    Mueller WH, Grunbaum JA, Labarthe DR. Anger expression, body fat, and blood pressure in adolescents: Project HeartBeat! Am J Hum Biol. 2001 Jul-Aug;13(4):531-8. doi: 10.1002/ajhb.1085.
    Results Reference
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