Cardiovascular Diseases Clinical Trial
To foster collaboration between the World Health Organization MONICA Project and the NHLBI Study of Atherosclerosis Risk in Communities (ARIC). To ensure that valid comparisons could made between findings in MONICA and ARIC by supporting activities to standardize coding, classification, and analysis of coronary and stroke events, risk factors, and medical care according to MONICA protocol.
BACKGROUND:
The MONICA Project was undertaken by the World Health Organization (WHO) as a ten year
international effort to measure the trends in cardiovascular mortality and coronary heart
disease and cerebrovascular disease morbidity and to assess the extent to which these trends
were related to changes in known risk factors, daily living habits, or major socioeconomic
features. Pilot studies were completed in 1981 in four countries and by 1985 there were 41
MONICA's in defined communities in 27 countries. Each study site covered a population of
around 300,000 persons and was expected to be studied for a decade. The centers measured the
incidence of cardiovascular disease--particularly coronary heart disease and cerebrovascular
diseases--and assessed the extent to which these trends were related to changes in known
risk factors (smoking, blood lipids, blood pressure, diet), daily living habits, health
care, and major socioeconomic factors in the study populations. MONICA was also expected to
introduce, in the countries concerned, new health statistical methods that would lead to
more effective use of national health information systems.
As an Associate Member of MONICA, NHLBI received copies of unclassified project
documentation and was represented at meetings of MONICA Principal Investigators. However,
central data analysis and quality control evaluations were not available to associate
members.
Under this contract, NHLBI received summary tabulations of: population demographics and
vital statistics including the numbers of total deaths and of cardiovascular, coronary heart
disease and stroke deaths among residents of each Reporting Unit; fatal and non-fatal
coronary and stroke events; ECG abnormalities, chest pain symptoms, and cardiac enzyme
measurements; population survey prevalence rates and distributions of risk factors including
but not limited to blood pressure, total cholesterol, other lipids and lipoproteins, height,
weight, and cigarette consumption; hospitalizations and medical care for cardiovascular
conditions; case fatality rates within 28 days of onset of a heart attack, stroke, or other
cardiovascular event. The NHLBI also received reports on the quality of the data and
performance at each site based on the circulation and evaluation of test case histories.
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Observational Model: Natural History
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