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AtherosclerosisNCT00005678

Multinational Monitoring of Trends and Determinants in Cardiovascular Disease (MONICA)

An observational study of Atherosclerosis and Cardiovascular Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 0 years and older, men only
How many people
Not given
Where
No sites listed yet
Study dates
Jul 1984to Apr 1996
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 0 years and older
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

No eligibility criteria

About this study

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.

Read the detailed description

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.

Medical subject headings
Atherosclerosis, Cardiovascular Diseases, Stroke, Coronary Disease, Heart Diseases

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2000 (estimated)
  2. Study startJul 1984
  3. Study completionApr 1996

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Natural history
IDs, dates and publications
ClinicalTrials.gov ID
NCT00005678
Sponsor's protocol ID
1037
Status last verified
May 2000
First submitted
25 May 2000
Last updated
24 Jun 2005
Results posted
No

Publications

  • The World Health Organization MONICA Project (monitoring trends and determinants in cardiovascular disease): a major international collaboration. WHO MONICA Project Principal Investigators. J Clin Epidemiol. 1988;41(2):105-14. doi: 10.1016/0895-4356(88)90084-4.

    PubMed 3335877
  • Bothig S. WHO MONICA Project: objectives and design. Int J Epidemiol. 1989;18(3 Suppl 1):S29-37.

    PubMed 2807705

Questions about this trial

What is this clinical trial studying?

An observational study of Atherosclerosis and Cardiovascular 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 24 Jun 2005. 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 NCT00005678, which also lists 2 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 24 Jun 2005.

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