Elsevier

American Heart Journal

Volume 144, Issue 2, August 2002, Pages 212-218
American Heart Journal

Trial Design
Assessment of clinically silent atherosclerotic disease and established and novel risk factors for predicting myocardial infarction and cardiac death in healthy middle-aged subjects: Rationale and design of the Heinz Nixdorf RECALL Study,☆☆,

https://doi.org/10.1067/mhj.2002.123579Get rights and content

Abstract

Background In view of consistently high cardiovascular morbidity and mortality rates, international efforts are aimed at developing tools for more precise risk prediction to allow preventive treatment targeted at high-risk individuals. Direct visualization of anatomic, preclinical atherosclerotic disease has the potential for individualized risk discrimination. Further, a variety of risk factors are actively evaluated, including markers of the activity of atherosclerotic disease, thrombogenic risk, and genetic polymorphisms. Methods The Heinz Nixdorf RECALL (Risk Factors, Evaluation of Coronary Calcium and Lifestyle) study is a population-based, prospective cohort study of the comparative value of modern risk stratification techniques for “hard” cardiac events. It is designed and powered to define the relative risk associated with the specific extent of coronary atherosclerosis measured by means of electron-beam computed tomography (EBCT)-derived coronary calcium quantities for myocardial infarction and cardiac death in 5 years in 4200 males and females aged 45 to 75 years in an unselected urban population from the large, heavily industrialized Ruhr area. Additionally, the predictive values of conventional cardiovascular risk factors, new candidate and socioeconomic risk factors, certain genetic polymorphisms, and direct signs of subclinical disease are examined with the ankle-brachial index, resting and stress electrocardiograms, and determination of carotid artery intima-media thickness. Prospective clinical risk-benefit and health economic analyses are an inherent part of the study. Study findings with established clinical significance are reported to the participants, but the EBCT findings are withheld until the conclusion of the study. Conclusions The Heinz Nixdorf RECALL study will define appropriate methods for identifying high-risk subgroups in the general urban population who may derive the greatest benefit from preventive treatment. (Am Heart J 2002;144:212-8.)

Section snippets

Overview

The overall study group is randomly selected from mandatory registries of residence of the cities of Bochum, Essen, and Mülheim, Germany. These cities belong to the Ruhr area, which can be seen as a conglomeration of large, industrial cities. The presence of overt cardiovascular disease (expected in 12% of the 4200 participants) leads to exclusion from the primary analysis, but not from the study. A targeted assessment of medical history and physical examination are performed in all

Discussion

The Heinz Nixdorf RECALL study provides a large database on the prognostic power of various modern tests in predicting cardiovascular events in the general population. An important focus is the noninvasive determination of the extent of coronary atherosclerosis by means of quantification of coronary calcium with EBCT. It is hypothesized that by directly measuring the anatomic extent of coronary atherosclerosis, EBCT provides a link between coronary risk factors and ischemic heart disease and

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    Supported by the Heinz Nixdorf Foundation, Essen, Germany. The health-economic evaluation is supported by the German Bundesministerium für Bildung und Forschung. Additional support was provided by Imatron Inc, South San Francisco, Calif, and General Electrics Medical Systems Deutschland, Neu-Isenburg, Germany.

    ☆☆

    Reprint requests: Axel Schmermund, MD, Department of Cardiology, University Clinic Essen, Hufelandstraße 55, D-45122 Essen, Germany.

    E-mail: [email protected]

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