Cardiovascular DiseasesNCT00005122
Evans County Studies
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To conduct surveillance of cardiovascular morbidity and mortality and its correlation with known risk factors in all cohort study groups in Evans County, Georgia. 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, Myocardial Infarction
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jul 1958to Aug 1995
- 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 conduct surveillance of cardiovascular morbidity and mortality and its correlation with known risk factors in all cohort study groups in Evans County, Georgia.
Read the detailed description
BACKGROUND:
The Evans County Studies were initiated as a result of a request from the National Heart Institute in the late 1950's to develop epidemiological studies in areas where significant racial or ethnic differences in cardiovascular disease rates had been observed and where a stable population was available for long-term follow-up. Evans County was in a region of the United States known, at the time, to have the highest total death rates for all causes, of which coronary heart disease and hypertension were major contributors. At that time, Black males and females were known to have four times less coronary heart disease than white males, showed no sex differences for coronary heart disease mortality, and consumed more animal fat and had 50 percent more hypertension.
In 1960, the original Evans County Study cohort was formed when 92 percent of all residents, Black and white, aged 40-74 years and a 50 percent sample of residents aged 15-39 years were given a complete physical examination and a variety of laboratory tests. The major purpose of the original study was to determine factors associated with coronary and related cardiovascular diseases and to explain the low frequency of coronary heart disease in Blacks. Of the initial cohort of 3,102 individuals in 1960, approximately 2,500 were re-examined from 1967 to 1969. Variables studied included serum lipid levels, blood pressure, blood clotting factors, catecholamine levels, physical activity, and social, psychological, and economic factors. Necropsy data were also collected. Follow-up continued on the remaining cohort of approximately 1,900.
Over the years many additional studies were added. The Lipoprotein Phenotyping Study examined which fraction or fractions of high density lipoproteins or low density lipoproteins were related to increased risk for coronary heart disease. The Black-White Neonatal Blood Pressure Study related blood pressure levels during the first year of life to the subsequent development of hypertension and comparing similar groups in other geographical areas to the Evans County group. The Contraceptive Steroids on Blood Pressure Study, funded by the National Institute of Child Health and Human Development, related antecedent characteristics to the development of hypertension or thrombotic disease in the first time oral contraceptive user. The Evans County Health Department also participated Hypertension Detection and Followup Program clinical trial and continued surveillance of the cohort.
Other studies included: the use of defined biracial pedigree cohorts as genetic models to define the possible inheritance of hypertension, hyperlipidemias, coronary heart disease, and thrombosis; maintenance of a collection of frozen sera and food; evaluating new tests to indicate differences in intravascular coagulation between racial and social class groups as related to physical activity, social mobility, and dietary deficiency; studies of the possible relationship to hypertension of dietary sodium-potassium and calcium and selenium intake.
DESIGN NARRATIVE:
Follow-up of the original Evans County Study cohort was achieved by contacting each member annually by mail, telephone, or personal visit, weekly surveys of all admissions at the Evans Memorial Hospital and Statesboro Hospital; survey of daily obituaries in the local newspapers. In the event of a death, autopsy reports and hospital records were obtained. Twice a year teams of consulting neurologists and cardiologists visited Evans County to examine all suspected surviving cases of stroke, transient ischemic attack, myocardial infarction, and angina pectoris. Home visits were conducted for patients who did not visit the medical facility.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Myocardial Infarction, Angina Pectoris, Cerebrovascular Accident, Coronary Disease
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Myocardial Infarction, Angina Pectoris, Stroke, Coronary Disease, Ischemic Attack, Transient
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 startJul 1958
- Study completionAug 1995
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (178)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
- NCT00005122
- Sponsor's protocol ID
- 901
- Other IDs
- R37HL003341
- Status last verified
- Jun 2000
- First submitted
- 25 May 2000
- Last updated
- 16 Mar 2016
- Results posted
- No
Publications
Fodor JG, Heyden S, Chockalingam A, Logan AG, Hames CG. The P-wave in the electrocardiogram of hypertensive patients before and after therapy. Can J Cardiol. 1986 Sep-Oct;2(5):264-7.
PubMed 3768785Curb JD, Borhani NO, Blaszkowski TP, Zimbaldi N, Fotiu S, Williams W. Patient-perceived side effects to antihypertensive drugs. Am J Prev Med. 1985 Jan-Feb;1(1):36-40.
PubMed 3870892Johnson MA, Dooley SP, Caster WO, Hames CG: The Relationship Between Dietary Calcium and Blood Pressure in the Elderly. J Clin Exp Gerontology, 8: (3 & 4), 161-172, 1986
Smith DK, Teague RJ, McAdam PA, Feldman DS, Feldman EB. Selenium status of malnourished hospitalized patients. J Am Coll Nutr. 1986;5(3):243-52. doi: 10.1080/07315724.1986.10720128.
PubMed 3090129Chen XS, Xue A, Morris VC, Ferrans VJ, Herman EH, el-Hage A, Levander OA. Effect of selenium deficiency on the chronic toxicity of adriamycin in rats. J Nutr. 1986 Dec;116(12):2453-65. doi: 10.1093/jn/116.12.2453.
PubMed 3806242Singh VK, Fudenberg HH. Immunopharmacological approach to the study of chronic brain disorders. Prog Drug Res. 1986;30:345-63. doi: 10.1007/978-3-0348-9311-4_10. No abstract available.
PubMed 3544047Marazita ML, Elston RC, Namboodiri KK, Hames CG. Genetic analysis of serum lipid levels and blood pressure in a large kindred. Am J Med Genet. 1987 Mar;26(3):511-9. doi: 10.1002/ajmg.1320260302.
PubMed 3565465Strogatz DS, Tyroler HA, Watkins LO, Hames CG. Electrocardiographic abnormalities and mortality among middle-aged black men and white men of Evans County, Georgia. J Chronic Dis. 1987;40(2):149-55. doi: 10.1016/0021-9681(87)90066-x.
PubMed 3818868Combs GF, Spallholz JE, Levander OA, Oldfield JE: Selenium in Biology and Medicine, Third lnternational Symposium, Beijing, China. Two Books, Parts A and B, published in 1987
Hames CG: An Urgent Methodological Need for Antioxidant Research as Seen by an Epidemiologist. Book, Selenium in Biology and Medicine, 3rd lnterntl Symposium, Beijing, China, Part B, 1987
Comberg HU, Knowles M, Tyroler HA, Heyden S, Hames CG, Sabo D. Status of patients seven years after completion of the hypertension detection and follow-up program in Evans County, Georgia. J Natl Med Assoc. 1988 Dec;80(12):1285-92.
PubMed 3249331Daniels SR, Heiss G, Davis CE, Hames CG, Tyroler HA. Race and sex differences in the correlates of blood pressure change. Hypertension. 1988 Mar;11(3):249-55. doi: 10.1161/01.hyp.11.3.249.
PubMed 3350588Somervell PD, Kaplan BH, Heiss G, Tyroler HA, Kleinbaum DG, Obrist PA. Psychologic distress as a predictor of mortality. Am J Epidemiol. 1989 Nov;130(5):1013-23. doi: 10.1093/oxfordjournals.aje.a115402.
PubMed 2816889Humble C, Croft J, Gerber A, Casper M, Hames CG, Tyroler HA. Passive smoking and 20-year cardiovascular disease mortality among nonsmoking wives, Evans County, Georgia. Am J Public Health. 1990 May;80(5):599-601. doi: 10.2105/ajph.80.5.599.
PubMed 2327539Moorman PG, Hames CG, Tyroler HA. Socioeconomic status and morbidity and mortality in hypertensive blacks. Cardiovasc Clin. 1991;21(3):179-94.
PubMed 1828391
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evans County Studies
- ClinicalTrials.gov ID
- NCT00005122
- Acronym / sponsor ID
- 901
- Conditions
- Cardiovascular Diseases, Heart Diseases, Myocardial Infarction, Angina Pectoris, Cerebrovascular Accident, Coronary Disease
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jul 1958
- Study completion
- Aug 1995 (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 conduct surveillance of cardiovascular morbidity and mortality and its correlation with known risk factors in all cohort study groups in Evans County, Georgia.
Detailed description
BACKGROUND:
The Evans County Studies were initiated as a result of a request from the National Heart Institute in the late 1950's to develop epidemiological studies in areas where significant racial or ethnic differences in cardiovascular disease rates had been observed and where a stable population was available for long-term follow-up. Evans County was in a region of the United States known, at the time, to have the highest total death rates for all causes, of which coronary heart disease and hypertension were major contributors. At that time, Black males and females were known to have four times less coronary heart disease than white males, showed no sex differences for coronary heart disease mortality, and consumed more animal fat and had 50 percent more hypertension.
In 1960, the original Evans County Study cohort was formed when 92 percent of all residents, Black and white, aged 40-74 years and a 50 percent sample of residents aged 15-39 years were given a complete physical examination and a variety of laboratory tests. The major purpose of the original study was to determine factors associated with coronary and related cardiovascular diseases and to explain the low frequency of coronary heart disease in Blacks. Of the initial cohort of 3,102 individuals in 1960, approximately 2,500 were re-examined from 1967 to 1969. Variables studied included serum lipid levels, blood pressure, blood clotting factors, catecholamine levels, physical activity, and social, psychological, and economic factors. Necropsy data were also collected. Follow-up continued on the remaining cohort of approximately 1,900.
Over the years many additional studies were added. The Lipoprotein Phenotyping Study examined which fraction or fractions of high density lipoproteins or low density lipoproteins were related to increased risk for coronary heart disease. The Black-White Neonatal Blood Pressure Study related blood pressure levels during the first year of life to the subsequent development of hypertension and comparing similar groups in other geographical areas to the Evans County group. The Contraceptive Steroids on Blood Pressure Study, funded by the National Institute of Child Health and Human Development, related antecedent characteristics to the development of hypertension or thrombotic disease in the first time oral contraceptive user. The Evans County Health Department also participated Hypertension Detection and Followup Program clinical trial and continued surveillance of the cohort.
Other studies included: the use of defined biracial pedigree cohorts as genetic models to define the possible inheritance of hypertension, hyperlipidemias, coronary heart disease, and thrombosis; maintenance of a collection of frozen sera and food; evaluating new tests to indicate differences in intravascular coagulation between racial and social class groups as related to physical activity, social mobility, and dietary deficiency; studies of the possible relationship to hypertension of dietary sodium-potassium and calcium and selenium intake.
DESIGN NARRATIVE:
Follow-up of the original Evans County Study cohort was achieved by contacting each member annually by mail, telephone, or personal visit, weekly surveys of all admissions at the Evans Memorial Hospital and Statesboro Hospital; survey of daily obituaries in the local newspapers. In the event of a death, autopsy reports and hospital records were obtained. Twice a year teams of consulting neurologists and cardiologists visited Evans County to examine all suspected surviving cases of stroke, transient ischemic attack, myocardial infarction, and angina pectoris. Home visits were conducted for patients who did not visit the medical facility.
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 16 Mar 2016.
- Background: PubMed 3768785Fodor JG, Heyden S, Chockalingam A, Logan AG, Hames CG. The P-wave in the electrocardiogram of hypertensive patients before and after therapy. Can J Cardiol. 1986 Sep-Oct;2(5):264-7.
- Background: PubMed 3870892Curb JD, Borhani NO, Blaszkowski TP, Zimbaldi N, Fotiu S, Williams W. Patient-perceived side effects to antihypertensive drugs. Am J Prev Med. 1985 Jan-Feb;1(1):36-40.
- BackgroundJohnson MA, Dooley SP, Caster WO, Hames CG: The Relationship Between Dietary Calcium and Blood Pressure in the Elderly. J Clin Exp Gerontology, 8: (3 & 4), 161-172, 1986
- Background: PubMed 3090129Smith DK, Teague RJ, McAdam PA, Feldman DS, Feldman EB. Selenium status of malnourished hospitalized patients. J Am Coll Nutr. 1986;5(3):243-52. doi: 10.1080/07315724.1986.10720128.
- Background: PubMed 3806242Chen XS, Xue A, Morris VC, Ferrans VJ, Herman EH, el-Hage A, Levander OA. Effect of selenium deficiency on the chronic toxicity of adriamycin in rats. J Nutr. 1986 Dec;116(12):2453-65. doi: 10.1093/jn/116.12.2453.
- Background: PubMed 3544047Singh VK, Fudenberg HH. Immunopharmacological approach to the study of chronic brain disorders. Prog Drug Res. 1986;30:345-63. doi: 10.1007/978-3-0348-9311-4_10. No abstract available.
- Background: PubMed 3565465Marazita ML, Elston RC, Namboodiri KK, Hames CG. Genetic analysis of serum lipid levels and blood pressure in a large kindred. Am J Med Genet. 1987 Mar;26(3):511-9. doi: 10.1002/ajmg.1320260302.
- Background: PubMed 3818868Strogatz DS, Tyroler HA, Watkins LO, Hames CG. Electrocardiographic abnormalities and mortality among middle-aged black men and white men of Evans County, Georgia. J Chronic Dis. 1987;40(2):149-55. doi: 10.1016/0021-9681(87)90066-x.
- BackgroundCombs GF, Spallholz JE, Levander OA, Oldfield JE: Selenium in Biology and Medicine, Third lnternational Symposium, Beijing, China. Two Books, Parts A and B, published in 1987
- BackgroundHames CG: An Urgent Methodological Need for Antioxidant Research as Seen by an Epidemiologist. Book, Selenium in Biology and Medicine, 3rd lnterntl Symposium, Beijing, China, Part B, 1987
- Background: PubMed 3249331Comberg HU, Knowles M, Tyroler HA, Heyden S, Hames CG, Sabo D. Status of patients seven years after completion of the hypertension detection and follow-up program in Evans County, Georgia. J Natl Med Assoc. 1988 Dec;80(12):1285-92.
- Background: PubMed 3350588Daniels SR, Heiss G, Davis CE, Hames CG, Tyroler HA. Race and sex differences in the correlates of blood pressure change. Hypertension. 1988 Mar;11(3):249-55. doi: 10.1161/01.hyp.11.3.249.
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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 16 Mar 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 NCT00005122, which also lists 178 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 16 Mar 2016.