SILVER-AMI: Outcomes in Older Persons With Heart Attacks (SILVER-AMI)

May 23, 2019 updated by: Yale University

SILVER-AMI: Risk Stratification in Older Persons With Acute Myocardial Infarction

SILVER-AMI is a research study of older persons who are admitted to the hospital with a heart attack. Patients will be interviewed in the hospital and again 6 months later. The researchers will also collect detailed medical record information to understand the effect of heart attacks on older persons.

The research team at Yale University will use this information to develop a risk model that can be used to help doctors predict recovery. The goal of the study is to help older people in the future make well-informed decisions about their health care during a heart attack.

Study Overview

Status

Completed

Conditions

Detailed Description

The overall objective of this study is to develop and validate risk stratification tools for older adults who have recently had an Acute Myocardial Infarction (AMI). While there is emerging interest in understanding the role of geriatric conditions as they pertain to cardiovascular outcomes, there is no standard, feasible assessment of older patients with AMI that can stratify their risk of subsequent morbidity and mortality. Currently available risk models are designed solely to predict clinical events (e.g. mortality, reinfarction). This is insufficient for shared decision making with older patients, who consistently rate maintenance of favorable health status as a top priority. This study will address these gaps by melding principles from geriatrics and cardiology to create post-AMI risk models specifically designed for older patients. This study is significant because older persons with AMI are a growing, yet understudied, population.

Dr. Sarwat Chaudhry at Yale University is conducting a multi-center, observational study designed to collect data about the post-AMI recovery period that will be used to generate risk models for older patients with AMI. The intent of the study is to use the knowledge from the data collected in SILVER-AMI to ultimately design interventions to improve the care and outcomes of older patients with AMI.

Study coordinators will screen older patients hospitalized with an AMI. Participants will be assessed at baseline prior to AMI hospital discharge through an interview, physical assessment and medical record review. One follow-up interview will be conducted approximately 6 months later by the Yale Follow-up Center. Clinical outcomes will be assessed for the follow-up period occurring 6 months post AMI hospitalization through self-report and medical record review.

Study Type

Observational

Enrollment (Actual)

3042

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Fort Smith, Arkansas, United States, 72901
        • Sparks Regional Medical Center
    • California
      • Los Alamitos, California, United States, 90720
        • Los Alamitos Internal Medical Group
      • Sacramento, California, United States, 95816
        • Mercy General Hospital
      • Santa Barbara, California, United States, 93105
        • Santa Barbara Cottage Hospital
      • Stockton, California, United States, 95204
        • St. Joseph's Medical Center
      • Torrance, California, United States, 90505
        • Torrance Memorial Medical Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado
      • Denver, Colorado, United States, 80204
        • Denver Health Medical Center
    • Connecticut
      • Bridgeport, Connecticut, United States, 06610
        • Bridgeport Hospital
      • Danbury, Connecticut, United States, 06810
        • The Danbury Hospital and the Western Connecticut Medical
      • Hartford, Connecticut, United States, 06105
        • Saint Francis Hospital and Medical Center
      • New Haven, Connecticut, United States, 06511
        • Yale University
    • Florida
      • Tampa, Florida, United States, 33613
        • Florida Hospital Pepin Heart Institute
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
      • Macon, Georgia, United States, 31201
        • The Corporation of Mercer University
      • Valdosta, Georgia, United States, 31602
        • South Georgia Medical Center
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • The Queen's Medical Center
    • Idaho
      • Boise, Idaho, United States, 83706
        • Saint Alphonsus Regional Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital
      • Chicago, Illinois, United States, 60637
        • The University of Chicago
      • Evanston, Illinois, United States, 60201
        • Northshore University Health System
    • Indiana
      • Fort Wayne, Indiana, United States, 46845
        • Parkview Research Center
      • Indianapolis, Indiana, United States, 46237
        • St. Francis Medical Group
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Iowa Heart Center
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Cardiovascular Research Foundation of Louisiana
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Meritus Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital, Inc.
      • Worcester, Massachusetts, United States, 01605
        • UMass Memorial Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-1287
        • University of Michigan Health Systems
      • Dearborn, Michigan, United States, 48123
        • Oakwood Hospital and Medical Center
      • Detroit, Michigan, United States, 48236
        • St. John Hospital & Medical Center
      • Grand Rapids, Michigan, United States, 49503
        • Spectrum Health Hospitals
      • Okemos, Michigan, United States, 48864
        • McLaren Cardiovascular Group
      • Traverse City, Michigan, United States, 49684
        • Munson Medical Center
    • Minnesota
      • Coon Rapids, Minnesota, United States, 55433
        • Metropolitan Cardiology Consultants
      • Minneapolis, Minnesota, United States, 55407
        • Minneapolis Heart Institute Foundation
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Mid America Heart Institute St. Luke's Hospital
      • Saint Louis, Missouri, United States, 63110
        • Washington University
      • Springfield, Missouri, United States, 65807
        • Cox Health
    • Montana
      • Missoula, Montana, United States, 59802
        • The International Heart Institute of Montana
    • Nebraska
      • Lincoln, Nebraska, United States, 68526
        • Nebraska Specialty Network
      • Omaha, Nebraska, United States, 68124
        • CHI-Health-Alegent Creighton Research
    • New Jersey
      • Bridgewater, New Jersey, United States, 08807
        • Advanced Heart Care, LLC
      • Englewood, New Jersey, United States, 07631
        • Englewood Hospital and Medical Center
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
      • Summit, New Jersey, United States, 07901
        • Overlook Medical Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Presbyterian Heart Group
    • New York
      • Bronx, New York, United States, 10461
        • Montefiore/Albert Einstein Medical Center
      • New York, New York, United States, 10016
        • New York University School of Medicine
      • New York, New York, United States, 10034
        • The Trustees of Columbia University in the City of New York
      • Roslyn, New York, United States, 11576
        • St. Francis Research & Educational Corporation
      • Stony Brook, New York, United States, 11794-8167
        • The Research Foundation for the State University of New York
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Mission Medical Associates, Inc. dba Asheville Cardiology Associates
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina At Chapel Hill
      • Winston-Salem, North Carolina, United States, 27103
        • Forsyth Medical Center
      • Winston-Salem, North Carolina, United States, 27157-1045
        • Wake Forest University Health Sciences
    • North Dakota
      • Fargo, North Dakota, United States, 57104
        • Sanford Research
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Oklahoma Heart Hospital Research Foundation
    • Oregon
      • Corvallis, Oregon, United States, 97330
        • Good Samaritan Hospital, Corvallis
      • Portland, Oregon, United States, 97239
        • Portland VA Medical Center
      • Portland, Oregon, United States, 97225
        • Providence Health & Services
      • Portland, Oregon, United States, 97239
        • OHSU: Oregon Health & Science University
    • Pennsylvania
      • Doylestown, Pennsylvania, United States, 18901
        • Doylestown Hospital
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
      • Pittsburgh, Pennsylvania, United States, 15261
        • University of Pittsburgh Medical Center
      • Sayre, Pennsylvania, United States, 18840
        • Donald Guthrie Foundation for Education and Research
      • Wynnewood, Pennsylvania, United States, 19096
        • Lankenau Hospital
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Rapid City Regional Hospital, Inc.
    • Texas
      • Waco, Texas, United States, 76712
        • Providence HealthCare Network
    • Virginia
      • Lynchburg, Virginia, United States, 24501
        • Stroobants Cardiovascular Center
      • Norfolk, Virginia, United States, 23507
        • Sentara Hospital
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University
    • West Virginia
      • Huntington, West Virginia, United States, 25702
        • St Mary's Medical Center
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54301
        • Bellin Memorial Hospital, Inc.
      • Milwaukee, Wisconsin, United States, 53233
        • Aurora Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Older adults admitted to the hospital with a heart attack

Description

Inclusion Criteria:

  1. Age ≥75 years upon admission to the hospital

  2. Elevation of cardiac markers within 24 hours of presentation to the hospital

    a. Troponin must rise above the upper limit of normal established by the hospital as a determinate of cardiac injury.

  3. Any one of the following:

    1. Symptoms of ischemia
    2. ECG with ischemic changes
    3. Imaging evidence of Infarction
    4. Intracoronary thrombus on angiography

Exclusion Criteria:

  1. Patient transferred from another hospital with a length of stay >48 hours at the referring hospital.
  2. Refused Informed Consent
  3. Decisional impairment with no legally authorized representative
  4. AMI is secondary to chest trauma
  5. AMI is secondary to in-patient procedure or surgery
  6. History of heart transplant
  7. Non-English/Non-Spanish speaking
  8. Inability to complete interview (e.g. comatose or aphasia)
  9. Inability to contact for follow-up (e.g. no access to phone, not living in the country)
  10. Currently a prisoner
  11. Death prior to enrollment
  12. Previously enrolled in SILVER-AMI
  13. Troponin elevation is the result of apical ballooning syndrome (i.e., Takotsubo)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All-cause hospital readmission
Time Frame: up to six months
up to six months

Secondary Outcome Measures

Outcome Measure
Time Frame
All-cause mortality
Time Frame: Up to six months
Up to six months
Decline in health status
Time Frame: up to six months
up to six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Sarwat Chaudhry, MD, Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

November 27, 2012

First Submitted That Met QC Criteria

December 18, 2012

First Posted (Estimate)

December 21, 2012

Study Record Updates

Last Update Posted (Actual)

May 28, 2019

Last Update Submitted That Met QC Criteria

May 23, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1205010311
  • 1R01HL115295-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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