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
About this trial
This is an observational trial for Cardiovascular Diseases
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00005262
First Posted
May 25, 2000
Last Updated
May 12, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
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
background
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
background
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
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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
background
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
background
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
background
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
background
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
background
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
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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
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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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Epidemiology of Idiopathic Dilated Cardiomyopathy (Washington, DC Dilated Cardiomyopathy Study)
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