SILVER-AMI: Outcomes in Older Persons With Heart Attacks

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sarwat Chaudhry, Yale University
ClinicalTrials.gov Identifier:
NCT01755052
First received: November 27, 2012
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

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
Acute Myocardial Infarction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: SILVER-AMI: Risk Stratification in Older Persons With Acute Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • All-cause hospital readmission [ Time Frame: up to six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All-cause mortality [ Time Frame: Up to six months ] [ Designated as safety issue: No ]
  • Decline in health status [ Time Frame: up to six months ] [ Designated as safety issue: No ]

Estimated Enrollment: 3100
Study Start Date: January 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Older adults admitted to the hospital with a heart attack

Criteria

Inclusion Criteria:

  1. Age ≥75 years upon admission to the hospital
  2. Elevation of cardiac markers within 24 hours of presentation to the hospital
  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 >24 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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01755052

  Hide Study Locations
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
Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States, 06105
Yale University
New Haven, Connecticut, United States, 06511
United States, Florida
Baptist Healthcare/Andrews Research and Education Institute
Gulf Breeze, Florida, United States, 32561
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, Idaho
Saint Alphonsus Regional Medical Center
Boise, Idaho, United States, 83706
United States, Illinois
The University Of Chicago
Chicago, Illinois, United States, 60637
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
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
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
Boston Medical Center
Boston, Massachusetts, United States, 02118
Brigham and Women's Hospital, Inc.
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
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
Mercy Hospital Joplin
Joplin, Missouri, United States, 64801
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
St. John's Mercy Medical Research Institute
Springfield, Missouri, United States, 65804
United States, Montana
The International Heart Institute of Montana
Missoula, Montana, United States, 59802
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
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
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157-1045
Forsyth Medical Center
Winston-Salem, North Carolina, United States, 27103
United States, Oregon
Good Samaritan Hospital, Corvallis
Corvallis, Oregon, United States, 97330
Portland VA Medical Center
Portland, Oregon, United States, 97239
OHSU: Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Doylestown Hospital
Doylestown, Pennsylvania, United States, 18901
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Donald Guthrie Foundation for Education and Research
Sayre, Pennsylvania, United States, 18840
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, South Dakota
Sanford Research/USD
Sioux Falls, South Dakota, United States, 57104
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
Sponsors and Collaborators
Sarwat Chaudhry
Investigators
Principal Investigator: Sarwat Chaudhry, MD Yale University
  More Information

No publications provided

Responsible Party: Sarwat Chaudhry, Principal Investigator, Coordinating Center, Yale University
ClinicalTrials.gov Identifier: NCT01755052     History of Changes
Other Study ID Numbers: GRANT10974014, 1R01HL115295-01
Study First Received: November 27, 2012
Last Updated: June 4, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 30, 2014