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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01755052
Recruitment Status : Active, not recruiting
First Posted : December 21, 2012
Last Update Posted : January 17, 2018
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Yale University

Brief Summary:

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.

Condition or disease
Acute Myocardial Infarction

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
Estimated Enrollment : 3100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: SILVER-AMI: Risk Stratification in Older Persons With Acute Myocardial Infarction
Study Start Date : January 2013
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Primary Outcome Measures :
  1. All-cause hospital readmission [ Time Frame: up to six months ]

Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: Up to six months ]
  2. Decline in health status [ Time Frame: up to six months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Older adults admitted to the hospital with a heart attack

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01755052

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Yale University Identifier: NCT01755052     History of Changes
Other Study ID Numbers: 1205010311
1R01HL115295-01 ( U.S. NIH Grant/Contract )
First Posted: December 21, 2012    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yale University:
Acute Myocardial Infarction
Heart Attack
Risk Factors
Quality of Care
Risk Models

Additional relevant MeSH terms:
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases