Design and rationale of the comprehensive evaluation of risk factors in older patients with AMI (SILVER-AMI) study.

John A Dodson,Harlan M Krumholz,Thomas M Gill,Mary Geda,Denise Acampora,Heather G Allore,Sarwat I Chaudhry,Peter Charpentier,Terrence E Murphy,Nancy Lorenze,Sui W Tsang,Mary E Tinetti

doi:10.1186/s12913-014-0506-4

Abstract

BackgroundWhile older adults (age 75 and over) represent a large and growing proportion of patients with acute myocardial infarction (AMI), they have traditionally been under-represented in cardiovascular studies. Although chronological age confers an increased risk for adverse outcomes, our current understanding of the heterogeneity of this risk is limited. The Comprehensive Evaluation of Risk Factors in Older Patients with AMI (SILVER-AMI) study was designed to address this gap in knowledge by evaluating risk factors (including geriatric impairments, such as muscle weakness and cognitive impairments) for hospital readmission, mortality, and health status decline among older adults hospitalized for AMI.Methods/DesignSILVER-AMI is a prospective cohort study that is enrolling 3000 older adults hospitalized for AMI from a recruitment network of approximately 70 community and academic hospitals across the United States. Participants undergo a comprehensive in-hospital assessment that includes clinical characteristics, geriatric impairments, and health status measures. Detailed medical record abstraction complements the assessment with diagnostic study results, in-hospital procedures, and medications. Participants are subsequently followed for six months to determine hospital readmission, mortality, and health status decline. Multivariable regression will be used to develop risk models for these three outcomes.DiscussionSILVER-AMI will fill critical gaps in our understanding of AMI in older patients. By incorporating geriatric impairments into our understanding of post-AMI outcomes, we aim to create a more personalized assessment of risk and identify potential targets for interventions.Trial registrationTrial registration number: NCT01755052.

Highlights

While older adults represent a large and growing proportion of patients with acute myocardial infarction (AMI), they have traditionally been under-represented in cardiovascular studies
Among patients hospitalized for acute myocardial infarction (AMI), one-third are 75 years or older [1]
The primary objective is to generate risk models that predict all-cause readmission, all-cause mortality, and decline in health status, that exceed the capabilities of currently available risk models in older adults

Summary

Introduction

While older adults (age 75 and over) represent a large and growing proportion of patients with acute myocardial infarction (AMI), they have traditionally been under-represented in cardiovascular studies. Despite emerging interest in understanding the role of geriatric conditions (such as physical and cognitive impairments) as they pertain to cardiovascular outcomes [3], the majority of studies examining risk have used administrative datasets that lack this information [5], and none of the currently available risk stratification tools for AMI incorporate geriatric conditions. These risk models have only modest discrimination in older patients [6,7], and were designed solely to predict clinical events (i.e., mortality, reinfarction) rather than patient-centered outcomes, such as health status. The purpose of this article is to describe the design, rationale, and methods of the SILVER-AMI study

Objectives

Methods

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Discussion

Conclusion