Cardiovascular DiseasesNCT00005153
Etiologic Risk Factors of Cardiovascular Malformations
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To identify genetic and environmental risk factors for congenital cardiac disease. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Defect, Congenital Heart
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Dec 1980to Nov 1998
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To identify genetic and environmental risk factors for congenital cardiac disease.
Read the detailed description
BACKGROUND:
Congenital heart disease represents a major segment of clinically significant birth defects and is associated with high mortality and morbidity in infancy, a childhood marred with physical limitations and repeated invasive procedures, and an adulthood with increased risk of medical and social problems. Previous research has been principally directed to clinical methods of diagnosis and treatment, but the need for prediction and prenatal counseling requires further knowledge of environmental and familial risk factors. Congenital heart disease is not one of the malformations monitored by the International Clearing House of Birth Defects Surveillance System. Surveillance which does include congenital heart disease may lack diagnostic accuracy among the various reporting sources. Accurate clinical studies lack comparative control information. As a result, the true epidemiologic features of cardiac defects remain obscure.
DESIGN NARRATIVE:
The design of the Baltimore-Washington Infant Study was that of a case-control study. All infants under one year of age with confirmed diagnoses of congenital heart disease were eligible for inclusion if they were residents of the study area which encompassed 53 area hospitals in Maryland, the District of Columbia and five counties in Virginia. Case enrollment was done through five pediatric cardiology centers and through a periodic search of the obstetrics and neonatal and pathology logs of the participating hospitals. Control selection was by random numbers and all resident births were eligible as controls except for those with congenital heart disease. Mothers of cases and controls were interviewed at home for demographic information, and information on maternal health, maternal medication, reproductive history, lifestyle, environmental exposures in the home, occupation, and agents transmitted to the mother by the father. Data were collected on the characteristics, drug use, habits, and occupations of the fathers. Vital records and birth certificates were abstracted for all cases and controls. Death certificates were also abstracted. Variables including drugs, lifestyle and home exposures, and occupation, were screened to identify which single factors were most importantly related to congenital heart disease.
Cases in which congenital heart disease was part of a genetic complex were evaluated separately for environmental exposures. Genetic data analysis focused on first degree relatives but extended family data were noted wherever available. The genetic data analyses included: estimation of recurrence risks in siblings for congenital heart disease with the same cardiac defect; any cardiac defect in the sibling; non cardiac birth defect and pregnancy loss in the family. Parental phenotype was investigated for the presence of birth defects and known genetic disorders. Twin births were assessed for concordance in zygosity. Hypotheses of genetic and environmental teratogenic and coteratogenic interactions were tested. Pathogenic mechanisms were further defined through anatomic and echocardiographic observations. The family inquiry was expanded to include cousins. Nutrition information was added on maternal vitamin A supplementation, protein, calories, and other nutrients.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Heart Defects, Congenital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startDec 1980
- Study completionNov 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (42)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005153
- Sponsor's protocol ID
- 1025
- Other IDs
- R37HL025629
- Status last verified
- Oct 2001
- First submitted
- 25 May 2000
- Last updated
- 29 Feb 2016
- Results posted
- No
Publications
Scanlon KS, Ferencz C, Loffredo CA, Wilson PD, Correa-Villasenor A, Khoury MJ, Willett WC. Preconceptional folate intake and malformations of the cardiac outflow tract. Baltimore-Washington Infant Study Group. Epidemiology. 1998 Jan;9(1):95-8.
PubMed 9430276Lurie IW, Ferencz C. VACTERL-hydrocephaly, DK-phocomelia, and cerebro-cardio-radio-reno-rectal community. Am J Med Genet. 1997 May 16;70(2):144-9. doi: 10.1002/(sici)1096-8628(19970516)70:23.0.co;2-y.
PubMed 9128933Lurie IW, Kappetein AP, Loffredo CA, Ferencz C. Non-cardiac malformations in individuals with outflow tract defects of the heart: the Baltimore-Washington Infant Study (1981-1989). Am J Med Genet. 1995 Oct 23;59(1):76-84. doi: 10.1002/ajmg.1320590116.
PubMed 8849016Teratogenicity of progestational agents. Teratology. 1984 Feb;29(1):131-46. doi: 10.1002/tera.1420290115. No abstract available.
PubMed 6701803Ferencz C, Rubin JD, McCarter RJ, Wilson PD, Brenner JI, Neill CA, Perry LW, Hepner SI, Downing JW: Association of Blood Disorders and Congenital Heart Disease (Letter). Teratology, 29(2):313, 1984
Ferencz C, Rubin JD, McCarter RJ, Wilson PD, Boughman JA, Brenner JI, Neill CA, Perry LW, Hepner SI, Downing JW. Hematologic disorders and congenital cardiovascular malformations: converging lines of research. J Med. 1984;15(5-6):337-54.
PubMed 6399520Ferencz C, Rubin JD, McCarter RJ, Brenner JI, Neill CA, Perry LW, Hepner SI, Downing JW. Congenital heart disease: prevalence at livebirth. The Baltimore-Washington Infant Study. Am J Epidemiol. 1985 Jan;121(1):31-6. doi: 10.1093/oxfordjournals.aje.a113979.
PubMed 3964990Ferencz C, Rubin JD, McCarter RJ, Brenner JI, Neill CA, Perry LW, Hepner SI, Downing JW. Maternal mitral valve prolapse and congenital heart disease in the offspring. Am Heart J. 1985 Oct;110(4):899-900. doi: 10.1016/0002-8703(85)90483-1. No abstract available.
PubMed 4050668Kaden GG, McCarter RJ, Johnson SF, Ferencz C. Physician-patient communication. Understanding congenital heart disease. Am J Dis Child. 1985 Oct;139(10):995-9. doi: 10.1001/archpedi.1985.02140120041025.
PubMed 4036904Rubin JD, Ferencz C, McCarter RJ, Wilson PD, Boughman JA, Brenner JI, Neill CA, Perry LW, Hepner SI, Downing JW. Congenital cardiovascular malformations in the Baltimore-Washington area. Md Med J. 1985 Nov;34(11):1079-83. No abstract available.
PubMed 3853721Rubin JD, Ferencz C. Subsequent pregnancy in mothers of infants with congenital heart disease. Pediatrics. 1985 Sep;76(3):371-4.
PubMed 4034297Ferencz C. The etiology of congenital cardiovascular malformations: observations on genetic risks with implications for further birth defects research. J Med. 1985;16(5-6):497-508.
PubMed 2937867Ferencz C. Offspring of fathers with cardiovascular malformations. Am Heart J. 1986 Jun;111(6):1212-3. doi: 10.1016/0002-8703(86)90034-7. No abstract available.
PubMed 3716999Boughman JA, Berg KA, Astemborski JA, Clark EB, McCarter RJ, Rubin JD, Ferencz C. Familial risks of congenital heart defect assessed in a population-based epidemiologic study. Am J Med Genet. 1987 Apr;26(4):839-49. doi: 10.1002/ajmg.1320260411.
PubMed 3591826Johnson SF, McCarter RJ, Ferencz C. Changes in alcohol, cigarette, and recreational drug use during pregnancy: implications for intervention. Am J Epidemiol. 1987 Oct;126(4):695-702. doi: 10.1093/oxfordjournals.aje.a114709.
PubMed 3498364
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etiologic Risk Factors of Cardiovascular Malformations
- ClinicalTrials.gov ID
- NCT00005153
- Acronym / sponsor ID
- 1025
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Dec 1980
- Study completion
- Nov 1998 (actual)
- First posted
- 26 May 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To identify genetic and environmental risk factors for congenital cardiac disease.
Detailed description
BACKGROUND:
Congenital heart disease represents a major segment of clinically significant birth defects and is associated with high mortality and morbidity in infancy, a childhood marred with physical limitations and repeated invasive procedures, and an adulthood with increased risk of medical and social problems. Previous research has been principally directed to clinical methods of diagnosis and treatment, but the need for prediction and prenatal counseling requires further knowledge of environmental and familial risk factors. Congenital heart disease is not one of the malformations monitored by the International Clearing House of Birth Defects Surveillance System. Surveillance which does include congenital heart disease may lack diagnostic accuracy among the various reporting sources. Accurate clinical studies lack comparative control information. As a result, the true epidemiologic features of cardiac defects remain obscure.
DESIGN NARRATIVE:
The design of the Baltimore-Washington Infant Study was that of a case-control study. All infants under one year of age with confirmed diagnoses of congenital heart disease were eligible for inclusion if they were residents of the study area which encompassed 53 area hospitals in Maryland, the District of Columbia and five counties in Virginia. Case enrollment was done through five pediatric cardiology centers and through a periodic search of the obstetrics and neonatal and pathology logs of the participating hospitals. Control selection was by random numbers and all resident births were eligible as controls except for those with congenital heart disease. Mothers of cases and controls were interviewed at home for demographic information, and information on maternal health, maternal medication, reproductive history, lifestyle, environmental exposures in the home, occupation, and agents transmitted to the mother by the father. Data were collected on the characteristics, drug use, habits, and occupations of the fathers. Vital records and birth certificates were abstracted for all cases and controls. Death certificates were also abstracted. Variables including drugs, lifestyle and home exposures, and occupation, were screened to identify which single factors were most importantly related to congenital heart disease.
Cases in which congenital heart disease was part of a genetic complex were evaluated separately for environmental exposures. Genetic data analysis focused on first degree relatives but extended family data were noted wherever available. The genetic data analyses included: estimation of recurrence risks in siblings for congenital heart disease with the same cardiac defect; any cardiac defect in the sibling; non cardiac birth defect and pregnancy loss in the family. Parental phenotype was investigated for the presence of birth defects and known genetic disorders. Twin births were assessed for concordance in zygosity. Hypotheses of genetic and environmental teratogenic and coteratogenic interactions were tested. Pathogenic mechanisms were further defined through anatomic and echocardiographic observations. The family inquiry was expanded to include cousins. Nutrition information was added on maternal vitamin A supplementation, protein, calories, and other nutrients.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2016.
- Background: PubMed 9430276Scanlon KS, Ferencz C, Loffredo CA, Wilson PD, Correa-Villasenor A, Khoury MJ, Willett WC. Preconceptional folate intake and malformations of the cardiac outflow tract. Baltimore-Washington Infant Study Group. Epidemiology. 1998 Jan;9(1):95-8.
- Background: PubMed 9128933Lurie IW, Ferencz C. VACTERL-hydrocephaly, DK-phocomelia, and cerebro-cardio-radio-reno-rectal community. Am J Med Genet. 1997 May 16;70(2):144-9. doi: 10.1002/(sici)1096-8628(19970516)70:23.0.co;2-y.
- Background: PubMed 8849016Lurie IW, Kappetein AP, Loffredo CA, Ferencz C. Non-cardiac malformations in individuals with outflow tract defects of the heart: the Baltimore-Washington Infant Study (1981-1989). Am J Med Genet. 1995 Oct 23;59(1):76-84. doi: 10.1002/ajmg.1320590116.
- Background: PubMed 6701803Teratogenicity of progestational agents. Teratology. 1984 Feb;29(1):131-46. doi: 10.1002/tera.1420290115. No abstract available.
- BackgroundFerencz C, Rubin JD, McCarter RJ, Wilson PD, Brenner JI, Neill CA, Perry LW, Hepner SI, Downing JW: Association of Blood Disorders and Congenital Heart Disease (Letter). Teratology, 29(2):313, 1984
- Background: PubMed 6399520Ferencz C, Rubin JD, McCarter RJ, Wilson PD, Boughman JA, Brenner JI, Neill CA, Perry LW, Hepner SI, Downing JW. Hematologic disorders and congenital cardiovascular malformations: converging lines of research. J Med. 1984;15(5-6):337-54.
- Background: PubMed 3964990Ferencz C, Rubin JD, McCarter RJ, Brenner JI, Neill CA, Perry LW, Hepner SI, Downing JW. Congenital heart disease: prevalence at livebirth. The Baltimore-Washington Infant Study. Am J Epidemiol. 1985 Jan;121(1):31-6. doi: 10.1093/oxfordjournals.aje.a113979.
- Background: PubMed 4050668Ferencz C, Rubin JD, McCarter RJ, Brenner JI, Neill CA, Perry LW, Hepner SI, Downing JW. Maternal mitral valve prolapse and congenital heart disease in the offspring. Am Heart J. 1985 Oct;110(4):899-900. doi: 10.1016/0002-8703(85)90483-1. No abstract available.
- Background: PubMed 4036904Kaden GG, McCarter RJ, Johnson SF, Ferencz C. Physician-patient communication. Understanding congenital heart disease. Am J Dis Child. 1985 Oct;139(10):995-9. doi: 10.1001/archpedi.1985.02140120041025.
- Background: PubMed 3853721Rubin JD, Ferencz C, McCarter RJ, Wilson PD, Boughman JA, Brenner JI, Neill CA, Perry LW, Hepner SI, Downing JW. Congenital cardiovascular malformations in the Baltimore-Washington area. Md Med J. 1985 Nov;34(11):1079-83. No abstract available.
- Background: PubMed 4034297Rubin JD, Ferencz C. Subsequent pregnancy in mothers of infants with congenital heart disease. Pediatrics. 1985 Sep;76(3):371-4.
- Background: PubMed 2937867Ferencz C. The etiology of congenital cardiovascular malformations: observations on genetic risks with implications for further birth defects research. J Med. 1985;16(5-6):497-508.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005153, which also lists 42 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2016.