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Epidemiology of Idiopathic Dilated Cardiomyopathy (Washington, DC Dilated Cardiomyopathy Study)

Primary Purpose

Cardiovascular Diseases, Heart Diseases, Myocardial Diseases

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
    NCT00005262
    Brief Title
    Epidemiology of Idiopathic Dilated Cardiomyopathy (Washington, DC Dilated Cardiomyopathy Study)
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    May 2000
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1990 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    June 1996 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    To identify risk factors for idiopathic dilated cardiomyopathy and to examine prognostic factors over a follow-up period of two to three years.
    Detailed Description
    BACKGROUND: Idiopathic dilated cardiomyopathy is an often fatal cause of heart failure in young adults which is characterized by dilatation of the ventricles, increased myocardial mass, and impairment of systolic function. Dilated cardiomyopathy is more common than hypertrophic and restrictive cardiomyopathy, and the symptoms and physical signs are those of left-sided and eventually right-sided heart failure. Histologic findings in the condition include nonspecific interstitial myocardial fibrosis and myocyte hypertrophy. Despite the large number of systemic or generalized disease processes which have been associated with secondary dilated cardiomyopathy, the majority of cases are idiopathic. Mortality rates from cardiomyopathy have increased dramatically since 1970, and in 1990 over 10,000 deaths annually were attributed to cardiomyopathy in the United States. DESIGN NARRATIVE: The study had a prospective case-control design. Medical records of possible cases of idiopathic dilated cardiomyopathy who were discharged from five Washington, D. C. acute care hospitals over a two year period were abstracted so that standard diagnostic criteria could be applied. Two neighborhood controls were identified for each case. Cases and controls were matched on five year age intervals, sex, and telephone exchange. Cases were contacted annually during the two to three year follow-up period to determine vital status. The study determined whether the reported association between idiopathic dilated cardiomyopathy and asthma could be confirmed and the possible role of asthma medications, cigarette smoking, moderate alcohol consumption, and diabetes mellitus in the etiology of idiopathic dilated cardiomyopathy. The role of hypertension was also studied.. Statistical analysis consisted of case-control comparisons using conditional logistic regression techniques, and survival analyses using Kaplan-Meier curves and proportional hazards models. The study was also known as the Washington, D.C. Dilated Cardiomyopathy Study. Dr. Coughlin started his research at Georgetown University in Washington, D.C. and transferred to Tulane University. 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, Myocardial Diseases, Asthma, Diabetes Mellitus, Hypertension

    7. Study Design

    10. Eligibility

    Sex
    Male
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    No eligibility criteria

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    9145633
    Citation
    Coughlin SS, Myers L, Michaels RK. What explains black-white differences in survival in idiopathic dilated cardiomyopathy? The Washington, DC, Dilated Cardiomyopathy Study. J Natl Med Assoc. 1997 Apr;89(4):277-82.
    Results Reference
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    PubMed Identifier
    8904678
    Citation
    Metayer C, Coughlin SS, Mather FJ. Does cigarette smoking paradoxically increase survival in idiopathic dilated cardiomyopathy?. The Washington, D.C., Dilated Cardiomyopathy Study. Cardiology. 1996 Nov-Dec;87(6):502-8. doi: 10.1159/000177146.
    Results Reference
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    PubMed Identifier
    8899390
    Citation
    Coughlin SS, Rice JC. Obesity and idiopathic dilated cardiomyopathy. Epidemiology. 1996 Nov;7(6):629-32. doi: 10.1097/00001648-199611000-00011.
    Results Reference
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    PubMed Identifier
    8610701
    Citation
    Coughlin SS, Tefft MC, Rice JC, Gerone JL, Baughman KL. Epidemiology of idiopathic dilated cardiomyopathy in the elderly: pooled results from two case-control studies. Am J Epidemiol. 1996 May 1;143(9):881-8. doi: 10.1093/oxfordjournals.aje.a008831.
    Results Reference
    background
    PubMed Identifier
    1432004
    Citation
    Coughlin SS, Pickle LW, Goodman MT, Wilkens LR. The logistic modeling of interobserver agreement. J Clin Epidemiol. 1992 Nov;45(11):1237-41. doi: 10.1016/0895-4356(92)90164-i.
    Results Reference
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    PubMed Identifier
    1637897
    Citation
    Coughlin SS, Beauchamp TL. Ethics, scientific validity, and the design of epidemiologic studies. Epidemiology. 1992 Jul;3(4):343-7. doi: 10.1097/00001648-199207000-00009.
    Results Reference
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    PubMed Identifier
    1576224
    Citation
    Coughlin SS, Pickle LW. Sensitivity and specificity-like measures of the validity of a diagnostic test that are corrected for chance agreement. Epidemiology. 1992 Mar;3(2):178-81. doi: 10.1097/00001648-199203000-00017.
    Results Reference
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    PubMed Identifier
    1738006
    Citation
    Coughlin SS, Trock B, Criqui MH, Pickle LW, Browner D, Tefft MC. The logistic modeling of sensitivity, specificity, and predictive value of a diagnostic test. J Clin Epidemiol. 1992 Jan;45(1):1-7. doi: 10.1016/0895-4356(92)90180-u.
    Results Reference
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    PubMed Identifier
    2000848
    Citation
    Coughlin SS, Nass CC, Pickle LW, Trock B, Bunin G. Regression methods for estimating attributable risk in population-based case-control studies: a comparison of additive and multiplicative models. Am J Epidemiol. 1991 Feb 1;133(3):305-13. doi: 10.1093/oxfordjournals.aje.a115875.
    Results Reference
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    PubMed Identifier
    2218806
    Citation
    Coughlin SS, Chiazze L Jr. Job-exposure matrices in epidemiologic research and medical surveillance. Occup Med. 1990 Jul-Sep;5(3):633-46.
    Results Reference
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    PubMed Identifier
    7625404
    Citation
    Coughlin SS, Metayer C, McCarthy EP, Mather FJ, Waldhorn RE, Gersh BJ, DuPraw S, Baughman KL. Respiratory illness, beta-agonists, and risk of idiopathic dilated cardiomyopathy. The Washington, DC, Dilated Cardiomyopathy Study. Am J Epidemiol. 1995 Aug 15;142(4):395-403. doi: 10.1093/oxfordjournals.aje.a117647.
    Results Reference
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    PubMed Identifier
    7730876
    Citation
    Benton RE, Coughlin SS, Tefft MC. Predictors of coronary angiography in patients with idiopathic dilated cardiomyopathy: the Washington, DC Dilated Cardiomyopathy Study. J Clin Epidemiol. 1994 May;47(5):501-11. doi: 10.1016/0895-4356(94)90297-6.
    Results Reference
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    PubMed Identifier
    7932836
    Citation
    Coughlin SS, Gottdiener JS, Baughman KL, Wasserman A, Marx ES, Tefft MC, Gersh BJ. Black-white differences in mortality in idiopathic dilated cardiomyopathy: the Washington, DC, dilated cardiomyopathy study. J Natl Med Assoc. 1994 Aug;86(8):583-91.
    Results Reference
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    PubMed Identifier
    7918816
    Citation
    Coughlin SS, Tefft MC. The epidemiology of idiopathic dilated cardiomyopathy in women: the Washington DC Dilated Cardiomyopathy Study. Epidemiology. 1994 Jul;5(4):449-55. doi: 10.1097/00001648-199407000-00012.
    Results Reference
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    PubMed Identifier
    8205273
    Citation
    Coughlin SS, Pearle DL, Baughman KL, Wasserman A, Tefft MC. Diabetes mellitus and risk of idiopathic dilated cardiomyopathy. The Washington, DC Dilated Cardiomyopathy Study. Ann Epidemiol. 1994 Jan;4(1):67-74. doi: 10.1016/1047-2797(94)90044-2.
    Results Reference
    background
    PubMed Identifier
    8173003
    Citation
    Coughlin SS. A ban on policy recommendations in epidemiology research papers? Surely, you jest! Epidemiology. 1994 Mar;5(2):257-8. doi: 10.1097/00001648-199403000-00018. No abstract available.
    Results Reference
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    PubMed Identifier
    8263572
    Citation
    Coughlin SS, Comstock GW, Baughman KL. Descriptive epidemiology of idiopathic dilated cardiomyopathy in Washington County, Maryland, 1975-1991. J Clin Epidemiol. 1993 Sep;46(9):1003-8. doi: 10.1016/0895-4356(93)90167-y.
    Results Reference
    background
    PubMed Identifier
    8452906
    Citation
    Coughlin SS, Labenberg JR, Tefft MC. Black-white differences in idiopathic dilated cardiomyopathy: the Washington DC dilated Cardiomyopathy Study. Epidemiology. 1993 Mar;4(2):165-72. doi: 10.1097/00001648-199303000-00013.
    Results Reference
    background
    PubMed Identifier
    7925727
    Citation
    Coughlin SS, Benichou J, Weed DL. Attributable risk estimation in case-control studies. Epidemiol Rev. 1994;16(1):51-64. doi: 10.1093/oxfordjournals.epirev.a036144. No abstract available.
    Results Reference
    background
    PubMed Identifier
    8296783
    Citation
    Coughlin SS, Neaton JD, Sengupta A, Kuller LH. Predictors of mortality from idiopathic dilated cardiomyopathy in 356,222 men screened for the Multiple Risk Factor Intervention Trial. Am J Epidemiol. 1994 Jan 15;139(2):166-72. doi: 10.1093/oxfordjournals.aje.a116978.
    Results Reference
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