Elsevier

American Heart Journal

Volume 151, Issue 4, April 2006, Pages 786.e1-786.e10
American Heart Journal

Trial Design
The REduction of Atherothrombosis for Continued Health (REACH) Registry: An international, prospective, observational investigation in subjects at risk for atherothrombotic events-study design

https://doi.org/10.1016/j.ahj.2005.11.004Get rights and content

Background

The risk of atherothrombosis is a large health care burden worldwide. With its global prevalence, there is a need to understand all the associated risk factors, both old and new, and their interdependencies in the development of this complex disease leading to myocardial infarction, ischemic stroke, and vascular death and, thus, the major cause of mortality throughout the world.

Methods

The REACH Registry sought to compile an international data set to extend our knowledge of atherothrombotic risk factors and ischemic events in the outpatient setting. The Registry will recruit approximately 68 000 outpatients in 44 countries across 6 major regions (Latin America, North America, Europe, Asia, the Middle East, and Australia) from >5000 physician outpatient practices. Patients aged ≥45 years with at least 3 atherothrombotic risk factors or documented cerebrovascular, coronary artery, or peripheral arterial disease will be enrolled. Medical history, risk factors, demographic information, and management will be collected at baseline, and clinical events that occur during the follow-up period of up to 2 years in duration will be recorded.

Conclusion

The REACH Registry offers an opportunity to provide a better understanding of the prevalence and clinical consequences of atherothrombosis in the outpatient setting in a wide range of patients from different parts of the world.

Section snippets

Study design

The REACH Registry is an international, prospective, observational registry with an 18- to 24-month period of follow-up (Figure 1). The study will be approved by local institutional review boards and all patients will give informed consent.

Study population. Patients will be eligible for enrollment into the REACH Registry if they are aged ≥45 years with at least 1 of the following 4 criteria: any combination of at least 3 atherosclerosis risk factors (as listed in Table I), documented CAD,

Discussion

It is known that individuals presenting for the first time with any atherosclerotic disease, whether CAD, cerebrovascular disease, or PAD, are at risk for subsequent vascular events either in the same or different arterial bed.3 Consequently, there is a need to develop strategies to prevent either the primary development of these clinical syndromes or to offer therapeutic interventions that might lower long-term event rates in these vulnerable populations. Major opportunities exist

Limitations

Although this is a large, global registry of atherothrombotic disease involving many parts of the world not previously explored, there are several important limitations to this study. The enrollment of patients will be attempted to be consecutive, but because of the logistics involved on a worldwide basis, it is not possible to ensure this with enrollment logs, particularly in busy clinical practices. Nevertheless, the enrollment at each site will occur quickly, suggesting that only limited

References (24)

  • J.I. Weitz et al.

    Diagnosis and treatment of chronic arterial insufficiency of the lower extremities: a critical review

    Circulation

    (1996)
  • J.J. Belch et al.

    Prevention of atherothrombotic disease network. Critical issues in peripheral arterial disease detection and management: a call to action

    Arch Intern Med

    (2003)
  • Cited by (0)

    The REACH Registry is supported by Sanofi-Aventis, Paris, France, Bristol-Myers Squibb, New York, NY, and Waksman Foundation (Japan), Tokyo, Japan. AJR is a statistician employed by Sanofi-Aventis.

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